491 Compliance Ethics Professional jobs in Singapore
Regulatory Affairs Specialist
Posted 4 days ago
Job Viewed
Job Description
Welcome diversity and apply as you are!
At Adisseo, we cherish the value of diversity whatever it may be.
By joining Adisseo , you will join committed people who make the difference every day to contribute to this challenge.
By joining Adisseo , you will integrate a dynamic international environment.
By joining Adisseo , you will discover a world full of opportunities for every stage of your career by being actor to your professional journey.
Job Title : Regulatory Affairs Specialist
We are seeking a meticulous and proactiveRegulatory Affairs Specialist to ensure compliance with global regulatory requirements and support business operations. This role involves managing licenses and registrations, advising internal stakeholders, and staying ahead of regulatory changes. This role will work closely with the regional regulatory team and report functionally to Senior Regulatory Affairs Specialist. The ideal candidate will be highly organized, possess strong analytical skills, and thrive in both independent and collaborative work environments.
Responsibilities
Key Responsibilities & Duties:
- Regulatory Compliance & Monitoring
- Maintain and update a centralized regulatory database to track product licenses, renewal deadlines, and compliance documents.
- Monitor regulatory updates from local country teams and assess their impact on business operations.
- Implement a tracking system to ensure timely renewals, submissions, and compliance with evolving regulations.
- Ensure proper implementation of global processes (e.g., labelling, document requests) and contribute to continuous improvement.
- Support by working with cross-functions to respond to customer audit purposes and regulatory agency queries.
- License & Registration Management
- Oversee end-to-end product registrations, including dossier preparation, submission, and follow-up with regulatory agencies.
- Renew licenses for existing products, ensuring adherence to labeling, MRL (Maximum Residue Limits), and safety requirements.
- Liaise with internal teams (R&D, Quality, Legal) and external stakeholders (regulatory bodies, third-party consultants) to resolve compliance issues.
- Prepare and submit regulatory dossiers for locally manufactured dilution products (Singapore-specific).
- Coordinate with Singapore authorities (e.g., SFA, NEA) to secure necessary approvals.
3. Documentation & System Maintenance
- Upload and maintain registration certificates, technical documents, and compliance records in the Product Lifecycle Management (PLM) system.
- Ensure data accuracy and completeness for audit readiness and regulatory inspections.
- Generate reports for management on registration statuses, expirations, and pending actions.
- Maintain records of formulation changes, batch records, and compliance certifications.
- Stakeholder Communication & Business Support
- Advise HQ, sales, and supply chain teams on regulatory considerations for:
- New product launches (e.g., registration pathways, labeling compliance)
- Product amendments (e.g., formulation changes, claims adjustments)
- Sharing of related information from local teams (eg. updated requirements for import/export from local teams).
- Respond to customer regulatory requests, including undesirable substances declarations, safety data sheets (SDS), and supplier compliance questionnaires.
- Prepare customized compliance statements for clients based on regional regulatory requirements.
- Hold monthly alignment calls with country regulatory teams and senior regulatory affairs executive to track registration progress and address challenges.
- Support sales and supply chain teams by providing regulatory guidance for product distribution and market access.
Qualifications
Qualifications & Skills:
Education & Experience:
- Bachelor’s/Master’s degree in Regulatory Affairs, Chemistry, Life Sciences, or a related field.
- 2-3 years of experience in regulatory affairs, preferably in agrochemicals, pharmaceuticals, or consumer goods.
- Experience with APAC regulatory frameworks (e.g., China, India, ASEAN) is a plus.
Technical Skills:
- Proficiency in regulatory databases (e.g., PLM, SAP) and MS Office (Excel, PowerPoint).
- Knowledge of GLP, GMP, and ISO standards for compliance documentation.
Soft Skills:
- Strong attention to detail – Ensures accuracy in submissions and compliance records.
- Proactive problem-solving – Anticipates regulatory hurdles and proposes solutions.
- Excellent communication – Clearly conveys complex regulations to non-experts.
- Collaborative mindset – Works effectively with cross-functional teams.
- Results-driven – Committed to meeting KPIs (e.g., on-time renewals, audit pass rates).
- Service-oriented – Supports internal teams with a solutions-focused approach.
- Long-term thinker – Aligns regulatory strategies with business growth.
Regulatory Affairs Executive
Posted 4 days ago
Job Viewed
Job Description
LUXASIA is the leading and largest beauty omnichannel brand-builder of Asia Pacific. Since 1986, it has successfully enabled market entry and brand growth for more than 100 luxury beauty brands, the likes of Albion, Aveda, Bvlgari, Calvin Klein, Creed, Diptyque, Hermes, La Prairie, Maison Francis Kurkdjian, Montblanc, Rabanne, Ferragamo, and SK-II. LUXASIA has established Joint Ventures with the likes of LVMH Group, Revlon (for Elizabeth Arden), Puig, Shiseido, and Orveon (for Laura Mercier). The Group's integrated brand-building capabilities include luxury retail, online commerce, consumer marketing & analytics, and supply chain management. LUXASIA is powered by a diverse and dynamic #OneTeam of 2700 talents across a growing footprint of 15 markets.
Why Join Us
At LUXASIA, we believe there is beauty within every talent – that is you. We grow you by building your competencies and unleashing your potential. We have curated a vast portfolio of over 100 luxury brands across Asia Pacific, and growing. Your work will enrich the lives of millions of consumers across the region. With us, you get to be an entrepreneur, running the business like it is your very own. We give you but not without guidance and genuine care. We are a diverse and inclusive team that is courageously innovative. Together as #OneTeam, we celebrate differences, embrace change, explore new ideas, take risks, fail fast, and drive results. While challenges at work are inevitable, the journey promises to be fulfilling.
With LUXASIA, an exciting career filled with robust professional growth awaits you. Isn’t that beautiful?
Job Responsibilities
- Ensure compliance of cosmetic products with Singapore’s Health Sciences Authority (HSA) requirements and ASEAN Cosmetic Directive (ACD).
- Prepare, review, and submit Product Notifications (PNs) in accordance with HSA guidelines. Follow up for CCPNs and ensure traceability to CCPNs are kept.
- Maintain regulatory databases and ensure timely product renewals, variations, and updates are captured.
- Monitor and interpret changes in local and regional cosmetic regulations, advising internal teams on impact.
- Review product labels, artwork, and marketing materials for regulatory compliance.
- Coordinate with internal departments (Marketing, Supply Chain, Legal) to support product launches and market entry.
- Liaise with external regulatory bodies and industry associations & principal suppliers when required.
- Support audits and inspections from regulatory authorities.
- Administrative functions related to upkeep of country product compliance activities. Prior working experience with SAP will be useful
- Advice and guide Mandatory Packaging Reporting submissions. Keep tab on new regulations from NEA. Coordinate with principal parties to gather packaging material data.
- Bachelor’s degree in Chemistry, or related discipline.
- 1–3 years of regulatory affairs experience, preferably in cosmetics, personal care, or OTC pharmaceuticals. Fresh graduates may also apply if holds a BSc, Hons Chemistry
- Knowledge of ASEAN Cosmetic Directive and Singapore HSA regulations.
- Strong attention to detail, organizational, and communication skills.
- Ability to work independently and in a cross-functional team environment.
- Hands on working expertise with PRISM, HSA
- User knowledge on database platforms; BOX, Veeva, COSIng, SAP etc would be added advantage
- Competent IT skills in basic programming, Visual Basics are most welcome
Do you have what it takes to succeed in a fast-paced and intense environment? Do you thrive on challenges? Do you want to bring innovative ideas to life? Are you keen to abandon the status quo, try new things, embrace failures as lessons, recover fast, yet always pursue excellence?
If so, you are the one we are looking for. JOIN US and let’s grow together.
Championing Diversity, Equity and Inclusion
LUXASIA aspires to build a One Team of talents that reflects the diversity of the communities in our operating markets. LUXASIA is committed to providing equal employment opportunities to all individuals, regardless of their race, colour, religion, gender, sexual orientation, age, disability, nationality or ethnic origin, cultural background, social group, marital status, or any other characteristics as provided by law.
To explore other careers opportunities, visit our careers page . If you have a question for us, please drop us an email here.
We regret to inform you that only shortlisted candidates will be contacted. Thank you.
Recruitment Privacy Notice
By proceeding with your application, you confirm that you have read LUXASIA's recruitment privacy notice and consent to the LUXASIA group collecting, processing and disclosing your personal datafor purposes specified in the notice.
Note To Staffing Agencies
Please DO NOT contact LUXASIA’s employees or Talent & Excitement (T&E) team in an attempt to present candidates for our roles. LUXASIA has our own panel of appointed agencies that we work with. Any agency who is interested to work with us must obtain prior written approval from LUXASIA’s T&E team before you submit candidates’ resumes, and then only in conjunction with a valid fully executed contract for service and in response to a specific job opening. LUXASIA will not pay a fee to any Agency that does not have such agreement in place. Thank you for your understanding.
#J-18808-LjbffrRegulatory Affairs Executive
Posted 8 days ago
Job Viewed
Job Description
LUXASIA is the leading and largest beauty omnichannel brand-builder of Asia Pacific. Since 1986, it has successfully enabled market entry and brand growth for more than 100 luxury beauty brands, the likes of Albion, Aveda, Bvlgari, Calvin Klein, Creed, Diptyque, Hermes, La Prairie, Maison Francis Kurkdjian, Montblanc, Rabanne, Ferragamo, and SK-II. LUXASIA has established Joint Ventures with the likes of LVMH Group, Revlon (for Elizabeth Arden), Puig, Shiseido, and Orveon (for Laura Mercier). The Group's integrated brand-building capabilities include luxury retail, online commerce, consumer marketing & analytics, and supply chain management. LUXASIA is powered by a diverse and dynamic #OneTeam of 2700 talents across a growing footprint of 15 markets.
Why Join Us
At LUXASIA, we believe there is beauty within every talent – that is you. We grow you by building your competencies and unleashing your potential. We have curated a vast portfolio of over 100 luxury brands across Asia Pacific, and growing. Your work will enrich the lives of millions of consumers across the region. With us, you get to be an entrepreneur, running the business like it is your very own. We give you but not without guidance and genuine care. We are a diverse and inclusive team that is courageously innovative. Together as #OneTeam, we celebrate differences, embrace change, explore new ideas, take risks, fail fast, and drive results. While challenges at work are inevitable, the journey promises to be fulfilling.
With LUXASIA, an exciting career filled with robust professional growth awaits you. Isn’t that beautiful?
Job Responsibilities
- Ensure compliance of cosmetic products with Singapore’s Health Sciences Authority (HSA) requirements and ASEAN Cosmetic Directive (ACD).
- Prepare, review, and submit Product Notifications (PNs) in accordance with HSA guidelines. Follow up for CCPNs and ensure traceability to CCPNs are kept.
- Maintain regulatory databases and ensure timely product renewals, variations, and updates are captured.
- Monitor and interpret changes in local and regional cosmetic regulations, advising internal teams on impact.
- Review product labels, artwork, and marketing materials for regulatory compliance.
- Coordinate with internal departments (Marketing, Supply Chain, Legal) to support product launches and market entry.
- Liaise with external regulatory bodies and industry associations & principal suppliers when required.
- Support audits and inspections from regulatory authorities.
- Administrative functions related to upkeep of country product compliance activities. Prior working experience with SAP will be useful
- Advice and guide Mandatory Packaging Reporting submissions. Keep tab on new regulations from NEA. Coordinate with principal parties to gather packaging material data.
- Bachelor’s degree in Chemistry, or related discipline.
- 1–3 years of regulatory affairs experience, preferably in cosmetics, personal care, or OTC pharmaceuticals. Fresh graduates may also apply if holds a BSc, Hons Chemistry
- Knowledge of ASEAN Cosmetic Directive and Singapore HSA regulations.
- Strong attention to detail, organizational, and communication skills.
- Ability to work independently and in a cross-functional team environment.
- Hands on working expertise with PRISM, HSA
- User knowledge on database platforms; BOX, Veeva, COSIng, SAP etc would be added advantage
- Competent IT skills in basic programming, Visual Basics are most welcome
Do you have what it takes to succeed in a fast-paced and intense environment? Do you thrive on challenges? Do you want to bring innovative ideas to life? Are you keen to abandon the status quo, try new things, embrace failures as lessons, recover fast, yet always pursue excellence?
If so, you are the one we are looking for. JOIN US and let’s grow together.
Championing Diversity, Equity and Inclusion
LUXASIA aspires to build a One Team of talents that reflects the diversity of the communities in our operating markets. LUXASIA is committed to providing equal employment opportunities to all individuals, regardless of their race, colour, religion, gender, sexual orientation, age, disability, nationality or ethnic origin, cultural background, social group, marital status, or any other characteristics as provided by law.
To explore other careers opportunities, visit our careers page . If you have a question for us, please drop us an email here.
We regret to inform you that only shortlisted candidates will be contacted. Thank you.
Recruitment Privacy Notice
By proceeding with your application, you confirm that you have read LUXASIA's recruitment privacy notice and consent to the LUXASIA group collecting, processing and disclosing your personal datafor purposes specified in the notice.
Note To Staffing Agencies
Please DO NOT contact LUXASIA’s employees or Talent & Excitement (T&E) team in an attempt to present candidates for our roles. LUXASIA has our own panel of appointed agencies that we work with. Any agency who is interested to work with us must obtain prior written approval from LUXASIA’s T&E team before you submit candidates’ resumes, and then only in conjunction with a valid fully executed contract for service and in response to a specific job opening. LUXASIA will not pay a fee to any Agency that does not have such agreement in place. Thank you for your understanding.
#J-18808-LjbffrRegulatory Affairs Specialist
Posted 11 days ago
Job Viewed
Job Description
Welcome diversity and apply as you are!
At Adisseo, we cherish the value of diversity whatever it may be.
By joining Adisseo , you will join committed people who make the difference every day to contribute to this challenge.
By joining Adisseo , you will integrate a dynamic international environment.
By joining Adisseo , you will discover a world full of opportunities for every stage of your career by being actor to your professional journey.
Job Title : Regulatory Affairs Specialist
We are seeking a meticulous and proactiveRegulatory Affairs Specialist to ensure compliance with global regulatory requirements and support business operations. This role involves managing licenses and registrations, advising internal stakeholders, and staying ahead of regulatory changes. This role will work closely with the regional regulatory team and report functionally to Senior Regulatory Affairs Specialist. The ideal candidate will be highly organized, possess strong analytical skills, and thrive in both independent and collaborative work environments.
Responsibilities
Key Responsibilities & Duties:
- Regulatory Compliance & Monitoring
- Maintain and update a centralized regulatory database to track product licenses, renewal deadlines, and compliance documents.
- Monitor regulatory updates from local country teams and assess their impact on business operations.
- Implement a tracking system to ensure timely renewals, submissions, and compliance with evolving regulations.
- Ensure proper implementation of global processes (e.g., labelling, document requests) and contribute to continuous improvement.
- Support by working with cross-functions to respond to customer audit purposes and regulatory agency queries.
- License & Registration Management
- Oversee end-to-end product registrations, including dossier preparation, submission, and follow-up with regulatory agencies.
- Renew licenses for existing products, ensuring adherence to labeling, MRL (Maximum Residue Limits), and safety requirements.
- Liaise with internal teams (R&D, Quality, Legal) and external stakeholders (regulatory bodies, third-party consultants) to resolve compliance issues.
- Prepare and submit regulatory dossiers for locally manufactured dilution products (Singapore-specific).
- Coordinate with Singapore authorities (e.g., SFA, NEA) to secure necessary approvals.
3. Documentation & System Maintenance
- Upload and maintain registration certificates, technical documents, and compliance records in the Product Lifecycle Management (PLM) system.
- Ensure data accuracy and completeness for audit readiness and regulatory inspections.
- Generate reports for management on registration statuses, expirations, and pending actions.
- Maintain records of formulation changes, batch records, and compliance certifications.
- Stakeholder Communication & Business Support
- Advise HQ, sales, and supply chain teams on regulatory considerations for:
- New product launches (e.g., registration pathways, labeling compliance)
- Product amendments (e.g., formulation changes, claims adjustments)
- Sharing of related information from local teams (eg. updated requirements for import/export from local teams).
- Respond to customer regulatory requests, including undesirable substances declarations, safety data sheets (SDS), and supplier compliance questionnaires.
- Prepare customized compliance statements for clients based on regional regulatory requirements.
- Hold monthly alignment calls with country regulatory teams and senior regulatory affairs executive to track registration progress and address challenges.
- Support sales and supply chain teams by providing regulatory guidance for product distribution and market access.
Qualifications
Qualifications & Skills:
Education & Experience:
- Bachelor’s/Master’s degree in Regulatory Affairs, Chemistry, Life Sciences, or a related field.
- 2-3 years of experience in regulatory affairs, preferably in agrochemicals, pharmaceuticals, or consumer goods.
- Experience with APAC regulatory frameworks (e.g., China, India, ASEAN) is a plus.
Technical Skills:
- Proficiency in regulatory databases (e.g., PLM, SAP) and MS Office (Excel, PowerPoint).
- Knowledge of GLP, GMP, and ISO standards for compliance documentation.
Soft Skills:
- Strong attention to detail – Ensures accuracy in submissions and compliance records.
- Proactive problem-solving – Anticipates regulatory hurdles and proposes solutions.
- Excellent communication – Clearly conveys complex regulations to non-experts.
- Collaborative mindset – Works effectively with cross-functional teams.
- Results-driven – Committed to meeting KPIs (e.g., on-time renewals, audit pass rates).
- Service-oriented – Supports internal teams with a solutions-focused approach.
- Long-term thinker – Aligns regulatory strategies with business growth.
Regulatory Affairs Specialist
Posted 13 days ago
Job Viewed
Job Description
Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.
Role OverviewWe are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences Authority (HSA) or prior experience in medical device regulatory affairs. The ideal candidate will manage medical device registrations, ensure compliance with regulations, and provide guidance on regulatory strategy.
Key Responsibilities- Prepare, review, and submit medical device registration dossiers to HSA. Monitor submissions in other ASEAN countries handled by local regulatory personnel.
- Advise on regulatory strategy, product classification, labeling, and compliance requirements.
- Monitor regulatory changes and provide guidance to ensure ongoing compliance in Singapore and ASEAN markets.
- Support post-market surveillance activities.
- Point of contact for manufacturers' regulatory team and regulatory authorities, ensuring smooth and timely registration processes.
- Minimum 2–5 years of regulatory affairs experience, either from prior work in HSA or a regulatory affairs role in medical devices.
- Strong knowledge of Singapore medical device regulations (HSA); familiarity with other ASEAN regulations is an advantage.
- Ability in speaking Chinese is a requirement.
- Strong organizational and project management skills; able to handle multiple submissions simultaneously.
- Familiarity with Therapeutic Products License (TPL) is preferred.
- Office-based role
- Monday – Friday, 9:00 am – 6:00 pm
- Location: 25 Bukit Batok Crescent, #09-13 The Elitist, Singapore
$4,100 – $5,300 monthly, based on experience
Why Join Us- Leverage your HSA or regulatory affairs experience to lead submissions across multiple medical device product lines.
- Work closely with clients and regulatory authorities in a high-impact role.
- Gain exposure to ASEAN regulatory environments while building professional expertise.
- Join a specialist regulatory company offering career growth and professional development opportunities.
Regulatory Affairs, Manager
Posted 20 days ago
Job Viewed
Job Description
- Salary Range MYR 7,000 - 7,999
- City Bandar Sri Damansara
- Country Malaysia
- Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory.
- Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA).
- Initiate, validate, review, plan, and strategize to ensure all products remain compliant with applicable statutory and regulatory requirements.
- Communicate regulatory updates to relevant internal stakeholders to ensure alignment across departments.
- Plan and drive process improvements, including the digitalization of Regulatory Affairs (RA) workflows.
- Oversee and maintain Medical Device Establishment/Dealer Licenses with the relevant authorities.
- Supervise pre-market regulatory activities including medical device registration, change notifications, and applications for special authorizations or exemptions with government bodies.
- Manage post-market regulatory obligations, including the reporting of device-related incidents and complaints, ensuring all submissions are timely and compliant with applicable requirements.
- Ensure compliance with advertisement and labeling regulations in each marketing territory.
- Oversee and supervise compliance with other regulatory requirements from authorities such as MOH (MY), HSA (SG), NEA (SG), IMDA (MY/SG), DVS (MY/SG), and AVS (MY/SG).
- Plan and lead the implementation of internal RA audits on an annual basis.
- Support external audits conducted by regulatory agencies, principals, and suppliers by providing regulatory input to minimize the risk of non-compliance findings.
- Provide regulatory support during internal audits of subsidiaries and associated companies across Southeast Asia.
- Collaborate with Conformity Assessment Bodies on product risk assessment and regulatory implementation changes.
- Support regulatory matters related to custom import requirements and documentation.
- Assist and oversee matters involving licensed pharmacists or qualified personnel, including Poison A License and inspections by the Ministry of Health.
- Possess a Bachelor’s Degree in Science or a related discipline, with a minimum of 7 years of relevant experience in a similar capacity.
- Proficient in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
- Demonstrated track record in team leadership, preferably with experience managing a team of five or more, with strong people management capabilities including coaching and training.
- Excellent communication and interpersonal skills, with the ability to engage with regulatory authorities, consultants, auditors, and foreign manufacturers,effectively.
- In-depth knowledge and hands-on experience in medical device registration and regulatory compliance, particularly in Malaysia, Singapore, and Indonesia.
- Solid understanding of quality management systems, specifically ISO 13485, ISO 9001, and GDPMD requirements.
- Basic biomedical knowledge with the ability to understand and interpret technical aspects of medical devices.
- Strong understanding of operational workflows, with the ability to identify inefficiencies and implement process improvements.
- Meticulous and detail-oriented, capable of working independently with minimal supervision.
- Possess strong analytical and presentation skills, with the ability to translate data into meaningful insights.
- Proactive, performance-driven, and results-oriented, with a strong sense of ethical integrity and accountability in project execution.
- Pharmacist background with a valid license will be an added advantage.
Regulatory Affairs – Singapore
Posted 24 days ago
Job Viewed
Job Description
What to Expect
- Establish and manage regulatory submission timelinesfor both new and existing products across key global markets
- Prepare and file global medical device applications and amendments, ensuring timely market access.
- Engage with regulatory authorities and distribution partnersto support product registrations
- Author and maintain EU MDR-compliant technical documentation, including notifications of change, and lead all EU regulatory initiatives.
- Conduct global regulatory impact assessmentsfor product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
- Act as the regulatory representative on cross-functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
- Interpret and apply international regulations, standards, and directivesto ensure ongoing global compliance.
- Review and approve product labelingto ensure compliance with global regulatory requirements.
- Support and participate in inspections and auditsconducted by global regulatory authorities.
Requirements
- Minimum 5 years of Experience
- Fluent English
If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) or email
Tagged as: Regulatory Affair
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Regulatory Affairs Intern

Posted 18 days ago
Job Viewed
Job Description
- Support to the SG RA team in the preparation and uploading of UDI data in HSA portal.
- Assist in preparation for new product registrations and renewals by ensuring completeness in registrations dossiers.
- Collaborate on regional regulatory projects for Greater Asia.
- Maintain accurate records related to product registrations.
- Establish and maintain registration plans and registered product listings.
- Support with communications with external stakeholders such as government agencies, consultants, and distributors.
- Provide regulatory support to internal departments including Marketing, Quality Assurance, Technical Support, and Manufacturing
**Job Description**
**Work location: The Strategy Office**
**MAIN RESPONSIBILITIES:**
+ Support to the SG RA team in the preparation and uploading of UDI data in HSA portal.
+ Assist in preparation for new product registrations and renewals by ensuring completeness in registrations dossiers.
+ Collaborate on regional regulatory projects for Greater Asia.
+ Maintain accurate records related to product registrations.
+ Establish and maintain registration plans and registered product listings.
+ Support with communications with external stakeholders such as government agencies, consultants, and distributors.
+ Provide regulatory support to internal departments including Marketing, Quality Assurance, Technical Support, and Manufacturing.
**Job Requirements:**
+ Grad/Under Grad Bachelor's Degree in Science/Engineering related discipline;
+ Possess knowledge and understanding of UDI regulations in SG;
+ Good understanding of Medical Device Regulations and ISO standards;
+ Strong knowledge of Microsoft Office Suite (Word, Excel, PowerPoint);
+ Ability to work independently, and able to manage multiple priorities simultaneously
Required Skills
Optional Skills
.
**Primary Work Location**
SGP The Strategy
**Additional Locations**
**Work Shift**
SG Normal Office (Singapore)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
We are seeking a highly skilled and experienced Regulatory Manager to join our team in the Asia Pacific region. This is an exciting opportunity for a professional with a strong background in regulatory affairs to contribute to the success of our organization.
About the Role:- Main liaison personnel with Head Quarters and all Partners on Regulatory matters for Asia Pacific countries
- Coordinate all queries, variations, submissions and registrations
- Handles product issues or complaints as well as quality issues
- Update of PDM (Product Data Management) records and Packaging records
- Maintain past dossiers and attend to queries relating to approved dossiers and dossier information
- Records of trademarks for APAC countries
- Maintenance of GTIN (Global Trade Item Number) information for products marketed in APAC countries
- Individual Case Safety Report (ICSR) monitoring, reporting & documentation for products marketed in Singapore
- Recall procedures, execution & documentation for products marketed in Singapore
- Coordination of recall procedures, execution & documentation for products marketed in APAC countries in accordance to local regulatory requirements
- Quarterly reporting of weekly literature screening outcomes
- Annual reconciliation of ICSRs (Individual Case Safety Report) for Singapore
- Coordinate with partners to reconcile the ICSRs for their respective countries
- Pharmacovigilance training
- Main Local Safety Officer (LSO) in liaison with Pharmacovigilance Department in HQ
- Submission of Product Quality Reports (PQRs) and Periodic Safety Update Reports in countries where it is legally required
- Degree in Pharmacy, Biology, Chemistry, or a related field
- 3-5 years of experience in regulatory affairs, preferably in herbal or pharmaceutical products
- Good understanding of regional health regulations
- Strong attention to detail and organizational skills
This role offers a challenging and rewarding career opportunity for a motivated and experienced professional. If you have the necessary skills and qualifications, we encourage you to apply.
Others:Please note that this job description is not an exhaustive list of duties and responsibilities, which may change over time.
Regulatory Affairs Associate
Posted today
Job Viewed
Job Description
Reporting to the Regulatory Affairs Manager, you will be responsible for assisting in Regulatory Affairs activities for clinical trials and marketing authorisation.
Responsibilities
• Assist with submission of applications and variations for clinical trials and marketing authorisation across all pipelines
• Support regulatory assessment of submission requirements based on relevant regulations
• Assist with administrative work necessary to support regulatory activities
• Review and provide input for regulatory documents
• Support any other duties assigned
Qualifications
• Degree in Biological, Chemistry, or a related field
• No experience required. Must have an interest in Regulatory Affairs
• Keen learner with a strong attention to detail and organizational skills
• Proficiency in English (written and spoken) is required