171 Regulatory Specialist jobs in Singapore

Regulatory Compliance Specialist

Singapore, Singapore beBeeCompliance

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Job Description

Key Responsibilities

The role of Regulatory Compliance Specialist involves ensuring regulatory submissions and approvals, preparing and submitting product registration dossiers to relevant authorities, maintaining knowledge of regional requirements, and reviewing product artwork and labels for compliance.

Cross-Department Collaboration

This position requires collaboration with various departments, including Quality Assurance, R&D, and Production, to ensure regulatory compliance throughout the product lifecycle. Additionally, it entails providing regulatory guidance for new product development and market expansion projects.

Required Skills and Qualifications
  • Knowledge of regulatory guidelines and standards in the region
  • Ability to prepare and submit product registration dossiers
  • Experience in cross-functional collaboration
Benefits

As a Regulatory Compliance Specialist, you will have the opportunity to work in a dynamic environment, contribute to the success of the organization, and develop your skills and expertise in regulatory compliance.

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Regulatory Compliance Specialist

Singapore, Singapore NETS

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Job Description

Regulatory Compliance Specialist – NETS
This role is responsible for ensuring the company’s adherence to all related and relevant compliance regulations. The incumbent will act as the compliance advisory for various departments and collaborate with them to ensure compliance with all applicable regulations while achieving the organization’s goals.
Responsibilities
Keep abreast of regulatory developments and changes impacting the company and advise the business units accordingly.
Ensure compliance with applicable laws, rules and regulations and apply sound ethical judgment regarding business practices and conduct.
Provide guidance to the business units on how to comply with relevant requirements in the context of issues and problems raised during normal business activities.
Work with the business units to identify and manage regulatory risk, including handling time-critical incident reporting to the authority.
Assess risk when business decisions are made, with due consideration for the company’s reputation and key stakeholders’ interests.
Develop and implement organizational policies, standards and procedures to comply with applicable regulations.
Develop, implement, and execute compliance testing, continuous assurance, and reporting of compliance testing reviews.
Conduct training to improve awareness of compliance policies and regulatory requirements.
Manage regulatory requests and inform senior management of significant compliance matters requiring their attention or action in a timely manner.
Requirements
Degree holder in computer science, information technology, information security, economics, accounting or related disciplines with at least 7 years of compliance experience in a regulated financial industry.
Possess strong analytical skills, paying careful and particular attention to detail.
Excellent problem-solving skills and ability to prioritize and manage multiple tasks.
Strong team player with a track record of working well in a collaborative environment with strong interpersonal and communication skills.
Strong in documentation and report writing skills.
Self-driven with the ability to operate independently.
Seniority level
Associate
Employment type
Full-time
Job function
Legal
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Regulatory Compliance Specialist Singapore

Singapore, Singapore Trust Bank

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Job Description

Overview
Trust is the first of a new breed of banks in Singapore – digitally native and focused on delivering a delightful customer experience. You will work in a fast-paced and collaborative environment to solve new and interesting challenges each day. Together with our Trust team, you will help shape the future of our bank and be able to work on and solve many interesting challenges which we are facing, learn new ways of working, and help build delightful high-quality products for our customers.
As a
Regulatory Compliance Specialist , you'd be able to work on and solve many interesting challenges which we are facing, learn new ways of working, and help build delightful innovative products and journeys for our customers.
Responsibilities
Provide advice and training on regulatory requirements, with a focus on the Securities and Futures Act, the Financial Advisers Act and associated regulations and guidelines, policies and standards of fair dealing and professional conduct.
Support the design and end-to-end implementation of appropriate RC and Conduct frameworks, policies and procedures for identifying, assessing, managing, monitoring, mitigating and reporting RC and Conduct risks, including data conduct, for digital-led retail wealth management and bancassurance in Singapore, and ensure effective management of issues and risks in collaboration with relevant stakeholders, and compliance with applicable regulations, policies and procedures.
Perform second line of defence role for managing RC and Conduct risks, facilitate the whistleblowing process, and escalate issues, as appropriate.
Keep abreast of regulatory developments, manage regulatory consultations and support regulatory change implementation.
Role Specific Technical Competencies
Singapore regulatory compliance advisory — Advanced
Data management compliance advisory — Core
Our Ideal Candidate
7 years of financial sector experience, with at least 5 years in RC second line of defence roles.
Possess advanced level of proficiency in compliance advisory on regulations, policies and standards, as well as core level of proficiency in data conduct.
Able to solve problems under pressure, innovate and achieve results sustainably.
Possess strong stakeholder management skills; able to collaborate and communicate effectively.
Good to have (Optional)
If you apply for a job with Trust or submit any personal information in connection with a possible job opportunity, you agree to our privacy notice for job applicants.
Come as you are!
Trust is an inclusive and open-minded workplace. If you are good at what you do and care about doing a good job, that’s what we focus and want from you. So come as you are.
Trust is an equal opportunity employer.
We prohibit discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Trust are based on business needs, job requirements and individual qualifications, without regard to age, gender, physical ability, race, religion or belief, family or parental status, sexuality, or any other status protected by laws or regulations. We will not tolerate discrimination or harassment based on any of these characteristics. We encourage applicants of all ages.
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If you are currently or formally a Standard Chartered employee applying for a role at Trust Bank, please let us know your Bank ID. If not applicable, kindly indicate as N.A: *
Do you require a visa to work in Singapore? * Select.
Are you currently/have you been in an audit partner role involved in an external audit engagement with Trust Bank? * Select.
Are you currently/have you been in an audit senior role (e.g. Audit Director or Audit Senior Manager) involved in an external audit engagement with Trust Bank? * Select.
Do you have experience in Singapore retail wealth management and bancassurance? * Select.
By answering 'Yes', you agree to the Trust Recruitment Privacy Notice * Select.
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Chief Regulatory Specialist

Singapore, Singapore beBeeRegulatory

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Job Description

Job Overview

This role is responsible for coordinating product registration across various countries. The successful candidate will provide regulatory assessment for new products or changes and advise internal teams on interpreting relevant guidance documents and standards.


Key Responsibilities:
  • To coordinate product registration (new and renewal) in designated countries, including provision of documents for dossier preparation and certificates within specified timeframe proactively to complete product registration.
  • Act as a point of contact between factories and the regulatory team of designated countries.
  • To provide regulatory assessment for new products or changes.
  • To advise internal and external teams on interpreting relevant guidance documents and standards.
  • To support preparation of documents for tender submissions.

Additional duties may be assigned by superiors from time to time.


Requirements:
  • Holds a degree in a relevant discipline.
  • Has a minimum of 3 years of relevant experience.

We are looking for someone with excellent communication skills who can work effectively in a fast-paced environment.

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Regulatory Specialist, Medical Devices

Singapore, Singapore Health Sciences Authority

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Job Description

(What the role is)
We are looking for highly motivated individuals with a strong desire to protect public health and safety to join us as Regulatory Specialists of Medical Devices.
(What you will be working on)
Screen and evaluate medical device pre/post-marketing applications to ascertain that medical devices meet safety, quality and performance requirements within target timelines.
Implementation of the medical device regulatory framework, including effective communication of the regulatory policy to industry and other stakeholders.
Respond to queries, feedback and provide clarifications to educate industry stakeholders on regulatory requirements and enhance regulatory compliance.
Conduct periodic environmental scanning of the medical device market to prepare for appropriate regulatory controls for novel innovative medical devices.
(What we are looking for)
Possess knowledge and experience in related scientific disciplines, e.g., Biomedical Engineering, Biomedical Sciences, Medical Technology, Pharmacy, Public Health or any related biomedical/ clinical specialties.
Preferably 3-5 years of relevant experience in the medical technology industry, including medical software.
Past research experience in R&D, biological sciences, bioengineering and biomedical areas will be an advantage but not essential.
Good communication and interpersonal skills.
Able to work independently, as well as in a team.
Able to work effectively with people from different backgrounds
Shortlisted candidates would be contacted within 30 days from the closing date of the advertisement. We regret that only shortlisted candidates would be notified.
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Healthcare Quality & Regulatory Specialist

079903 Anson Road, Singapore $6500 Monthly FLINTEX CONSULTING PTE. LTD.

Posted 4 days ago

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Job Description

This role is responsible to drive compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.


Responsibilities:

1. Quality Policies & Procedures:

Determine, implement & promote policies and procedures for Company’s Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others

2. Quality Assessment & Standards:

Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry

3. Compliance & Quality Program Management:

Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management:

Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System:

Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs:

Provide inputs to support the design & implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits

7. Certification Audits:

Lead and support various certification audits with relevant regulatory agencies and certification providers for the depot.

8. Operations & Customer Audit Programs:

Lead regular audit programs / random checks to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison:

Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and support in issue resolution via conducting root cause analysis (depot).

10. Healthcare Quality Feedback:

Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs:

Lead and support validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems


Requirements :

• Hold local pharmacist license

• Have 3-5 years of relevant experience in pharmaceutical or healthcare industry in a quality related role

• Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

• Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) for Medical Devices and other local certifications in a warehouse and transportation business.

• IATA CEIV will be desired but not necessary.

• Familiar with drugs control and secondary labelling system

• Experience in conducting external and internal audits

• Must hold at least Bachelor’s degree in Pharmacy from a reputable local institute.


Working hours:

Mon to Fri 9am-6pm



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Healthcare Quality & Regulatory Specialist

079903 Anson Road, Singapore $6500 Monthly FLINTEX CONSULTING PTE. LTD.

Posted 9 days ago

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Job Description

This role is responsible to drive compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.


Responsibilities:

1. Quality Policies & Procedures:

Determine, implement & promote policies and procedures for Company’s Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others

2. Quality Assessment & Standards:

Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry

3. Compliance & Quality Program Management:

Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management:

Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System:

Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs:

Provide inputs to support the design & implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits

7. Certification Audits:

Lead and support various certification audits with relevant regulatory agencies and certification providers for the depot.

8. Operations & Customer Audit Programs:

Lead regular audit programs / random checks to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison:

Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and support in issue resolution via conducting root cause analysis (depot).

10. Healthcare Quality Feedback:

Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs:

Lead and support validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems


Requirements :

• Hold local pharmacist license

• Have 3-5 years of relevant experience in pharmaceutical or healthcare industry in a quality related role

• Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

• Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) for Medical Devices and other local certifications in a warehouse and transportation business.

• IATA CEIV will be desired but not necessary.

• Familiar with drugs control and secondary labelling system

• Experience in conducting external and internal audits

• Must hold at least Bachelor’s degree in Pharmacy from a reputable local institute.



Working hours:

Mon to Fri 9am-6pm


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Regulatory Affairs Specialist

Singapore, Singapore Adisseo Group

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Job Description

Overview
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 proactive Regulatory 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.
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Regulatory Affairs Specialist

Singapore, Singapore JAC Recruitment Pte Ltd

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Job Description

Job Title:
Regulatory Affairs Specialist
Location:
Singapore
About Us:
The company is a global pharmaceutical company with significant presence in Asia, with operations in multiple countries.
Key Responsibilities:
Formulation of pharmaceutical strategies in collaboration with other teams and departments
Monitoring and tracking of pharmaceutical operations at each local company
Qualifications:
2-3+ years of experience in pharmaceutical business
Proactive, high level of initiative, communication/negotiation skills, logical thinking
Interested applicant, please click APPLY NOW
Do note that we will only be in touch if your application is shortlisted.
Peh Yong Sin
JAC Recruitment Pte Ltd
EA License Number: 90C3026
EA Personnel: R
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#countrysingapore
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Regulatory Affairs Specialist

Singapore, Singapore Poli Medical Company Pte Ltd

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Job Description

Company Description
Poli Medical Company Pte Ltd, founded in 1971, began as a patent medicine manufacturer specializing in chinese pharmaceuticals and health supplements. Over the years, it has expanded to offer contract manufacturing/OEM services of private label health and food/health supplements and marketing/distribution of related products. Today, Poli Medical operates one of the few pharmaceutical manufacturing facilities in Singapore certified by the Health Authority of Singapore (HSA) with GMP standards. The company offers over 200 SKUs, with around 100 registered with local authorities, and its products are available in countries including most of south east asia, Europe and the United States.
Role Description
This is a full-time hybrid role for a Regulatory Affairs Specialist. The Regulatory Affairs Specialist will be responsible for preparing regulatory documentation, ensuring compliance with regulatory requirements, managing regulatory submissions, and maintaining updated knowledge of regulatory affairs. The role involves working from home part-time and is located in Singapore.
Qualifications
Experience in Regulatory Documentation, Regulatory Compliance, and Regulatory Requirements
Knowledge and experience in Regulatory Affairs and Regulatory Submissions
Strong analytical and problem-solving skills
Excellent written and verbal communication skills
Attention to detail and ability to work independently
Bachelor's degree in a relevant field such as Pharmacy, Life Sciences, or Chemistry
Experience in the pharmaceutical industry is a plus
Seniority level
Entry level
Employment type
Full-time
Job function
Legal
Pharmaceutical Manufacturing
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