What Regulatory Affairs Specialist Jobs are in Singapore?
Showing 584 Regulatory Affairs Specialist jobs in Singapore
Job Description
Job Overview
This position requires a very high level of autonomy to support Andaman Medical in achieving regulatory goals and objectives. The Senior Regulatory Affairs Specialist is expected to drive best practices in office and administrative management within the organisation to maximise efficiency and growth. The main responsibility is to proactively support the organisation in achieving the necessary regulatory submissions needed for our clients and to develop and maintain worldwide regulatory knowledge.
Responsibilities
Senior Regulatory Affairs Specialist
- Investigating whether the Health Product is a medical device requiring registration with MOH, determining its risk classification and its route of submission.
- Preparing and submitting applications related to Initial, Renewal, Change Notification of medical device submissions, including follow up until approval.
- Promptly inform manufacturer is there’s any feedback from Authority to ensure successful product registration.
- Communicating with customers in respond to their regulatory concerns.
- Maintain regulatory database for the Company.
- Preparation of Regulatory Intelligence Report by carrying out proper research relating to the regulatory intelligence topic.
- Monitoring emerging trends regarding industry regulations to determine potential impact on internal projects and providing and drafting regulatory updates to Marketing Manager.
- Assist sales team in discussion with client on regulatory related matters (when required).
- Developing and maintaining Standard Operating Procedures, local working practices, regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Liaising with external parties on matters relating to medical device regulatory requirements.
- Carry out the reporting of post-marketing activities with Authority such as mandatory problem reporting, field safety correction action, recall and others.
- Ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain.
Qualifications
- At least a Bachelor’s Degree, Post-Graduate Diploma, Professional Degree, Biology,
- Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent. Graduated as pharmacist/apothecary.
- Minimum of 5 years of regulatory affairs experience in medical devices and /or IVD's, food supplements and cosmetics
Key Competencies
- Good management skills
- Fluent English and Mandarin with excellent writing and verbal communication skills
- Result oriented, can work with minimal supervision, and willing to assume increasing levels of responsibilities.
- Computer literate with advanced skills in Microsoft Office (Word, Power Point, etc.)
- At ease in working in a small structure, start-up-type, where tasks and responsibilities are in constant move.
- Able to operate in a multicultural environment.
- High level of autonomy at work, yet with profound team-spirit
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Quality and Regulatory Affairs Specialist
Posted 8 days ago
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Job Description
Essex Bio-Technology (“EssexBio”) is a bio-pharmaceutical company. Our portfolio of products aims to deliver solutions to commercial and clinical unmet needs, covering a wide range of therapeutic areas, which include Ophthalmology, Dermatology and Wound Healing. With a growing international presence across the U.S., Europe, and Asia, EssexBio offers employees the opportunity to participate in cross-border projects.
EssexBio is listed on the Hong Kong Stock Exchange with operating headquarters in Singapore and Zhuhai, serving Asia-Pacific and China respectively. In Singapore, EssexBio through its subsidiaries is focused on translational research, healthcare services and market access for biopharmaceutical products.
This job posting is for a role at our operating headquarters in Singapore (through one of our subsidiaries), offering the chance to contribute to EssexBio’s regional and global operations, strengthening our overall regional impact and innovation in healthcare.
About The Role
We are seeking a Quality and Regulatory Affairs (QRA) Specialist to support quality and regulatory activities for our products. In this role, you will ensure full QMS, oversee product quality processes, and supporting the full lifecycle management of products within our group.
This position offers potential regional exposure and the opportunity to build a progressive career in the QRA industry.
Key Responsibilities
Quality Assurance (QA)
- Assist in implementing and maintaining the company’s Quality Management System (QMS).
- Handle and manage QRA-related inspections.
- Maintain QRA-related licences and compliance.
- Manage new and existing supplier management activities.
- Manage investigations for deviation, non-conformity, CAPA and complaints.
- Review technical documentation and perform basic investigation.
Regulatory Affairs (RA) / Pharmacovigilance (PV)
- Lead and/ or manage drug safety detection activities.
- Coordinate and deliver internal training to ensure regulatory and quality compliance.
Others
- Manage and maintain all documents and records related to QRA, ensure regulatory compliance.
- Participate in the preparation of premarket regulatory submissions for commercial distribution.
- Ensure accurate records of training, roles and systems used in GxP functions.
- Support ad-hoc tasks and cross-functional initiatives when necessary.
Requirements
- Degree in Engineering, Life Sciences, Pharmacy, or a related discipline.
- Strong documentation, problem-solving, and communication skills.
- Exposure to Quality & Regulatory Affairs (QRA) activities, including QMS, SOP development, and inspection readiness.
- Familiarity with GDPMDS, GDP, regulatory inspections, and compliance is an advantage.
- Experience in regional QRA roles, SME distribution companies, or start-up / fast-growing environments is a plus.
- Non-pharmacists with relevant experience in QA, compliance, or pharmaceutical distribution are welcome.
- Fresh graduates with a pharmacist licence who are keen to build a career in the pharmaceutical industry are encouraged to apply.
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Job Description
Regulatory Affairs Specialist
1 year contract, potential to renew
Come and join us!
Do you wish to work in a world-class organization trying your hands at something you have dreamt of doing?
“FIND YOUR PLACE” by joining a world-class MNC Healthcare company
Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.
Company Description:
Our client is an MNC Healthcare company. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, they are empowered to tackle the world’s toughest health challenges, innovate through science and technology, and transform patient care.
General Description
The Regulatory Affairs Specialist MedTech is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices and pharmaceutical products under their responsibility. The position is responsible for providing input into the global regulatory strategy and identifying country requirements for successful regulatory filings for new products/indications and line extensions.
The Regulatory Affairs Specialist MedTech will be a member of the local regulatory affairs department within organization Medical, with responsibility to support the regulatory aspects of the assigned product portfolio/s
Key responsibilities:
- Preparation of submissions to the local health authority for new products, license renewals, and variations to existing products in line with Marketing launch plans, with guidance from senior regulatory colleagues as necessary
- Maintain departmental and source company databases of regulatory approvals
- Complete copy and labeling review as required
- Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of local regulatory requirements and request the documentation required for registration submissions
- Build constructive relationships with the local health authority and executes Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status.
- Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio
- Contribute to continuous review and improvement of processes within the Country Regulatory Affairs (RA) department to ensure consistent, efficient and effective practices
- Engage Marketing colleagues to strategize new product regulatory pathways, line extensions and changes to currently approved products and actively accelerate launch timelines.
- Leverages a solid working knowledge of the global regulatory environment, including proposed laws, regulations
Required Qualification and Core Competencies for the role:
- Bachelor's degree or equivalent in Biomedical Engineering / Biomedical Sciences / Life Sciences / Pharmacy / related discipline with minimum 1 year of experience
- Previous experience in preparing documents for health authority submissions (Clinical Trial Application, Chemistry & Manufacturing, and or Registration dossiers) is desirable;
- Ability to interpret complex issues and technologies and present them in simple terms to facilitate understanding by others;
- Demonstrated ability to handle multiple projects;
Interested parties, please apply through this link pool.com/projects OR click on APPLY button. Alternatively, you can share your CV at
EA License: 94C3609
Reg No: R
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Quality and Regulatory Affairs Specialist
Posted 4 days ago
Job Viewed
Job Description
At Majeton, we are driven by our commitment to deliver “The Right Product for Health”. Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products.
We are seeking a meticulous and experienced Quality & Regulatory Affairs Specialist to join our team and ensure regulatory compliance, uphold product quality, and oversee vigilance reporting for all of our marketed products.
About The Role
We are seeking a Quality and Regulatory Affairs (QRA) Specialist to support quality and regulatory activities for our products. In this role, you will ensure full QMS, oversee product quality processes, and supporting the full lifecycle management of products within our group.
This position offers potential regional exposure and the opportunity to build a progressive career in the QRA industry.
Key Responsibilities
Quality Assurance (QA)
- Assist in implementing and maintaining the company’s Quality Management System (QMS).
- Handle and manage QRA-related inspections.
- Maintain QRA-related licences and compliance.
- Manage new and existing supplier management activities.
- Manage investigations for deviation, non-conformity, CAPA and complaints.
- Review technical documentation and perform basic investigation.
Regulatory Affairs (RA) / Pharmacovigilance (PV)
- Lead and/ or manage drug safety detection activities.
- Coordinate and deliver internal training to ensure regulatory and quality compliance.
Others
- Manage and maintain all documents and records related to QRA, ensure regulatory compliance.
- Participate in the preparation of premarket regulatory submissions for commercial distribution.
- Ensure accurate records of training, roles and systems used in GxP functions.
- Support ad-hoc tasks and cross-functional initiatives when necessary.
Requirements
- Degree in Engineering, Life Sciences, Pharmacy, or a related discipline.
- Strong documentation, problem-solving, and communication skills.
- Exposure to Quality & Regulatory Affairs (QRA) activities, including QMS, SOP development, and inspection readiness.
- Familiarity with GDPMDS, GDP, regulatory inspections, and compliance is an advantage.
- Experience in regional QRA roles, SME distribution companies, or start-up / fast-growing environments is a plus.
- Non-pharmacists with relevant experience in QA, compliance, or pharmaceutical distribution are welcome.
- Fresh graduates with a pharmacist licence who are keen to build a career in the pharmaceutical industry are encouraged to apply.
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Senior Regulatory Affairs Specialist (Medical Device & Food Supplement) / East Area
Posted today
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Job Description
Our client is a global Medical device manufacturers providing healthcare regulatory consultancy across Asia. Due to their current expansion plan, they are looking for a Senior Regulatory Affairs Specialist to join their team, in hopes of developing the current high performing team. They are located in the East area.
Job Responsibilities:
- Determine whether products are classified as medical devices and identify appropriate regulatory pathways and risk classifications
- Prepare and submit regulatory applications including product registrations, renewals, and change notifications to relevant authorities
- Follow up on submissions and address authority feedback to support successful approvals
- Liaise with internal teams and external stakeholders to resolve regulatory queries and support product registration activities
- Maintain and update regulatory databases and ensure documentation accuracy and compliance
- Develop and maintain SOPs and internal regulatory policies to ensure compliance with regulatory requirements
- Conduct regulatory intelligence research and prepare reports on regulatory updates and industry developments
- Monitor regulatory changes and assess potential impact on ongoing projects, providing updates to stakeholders
- Support sales and commercial teams by providing regulatory advice during client discussions when required
- Handle post-market regulatory activities such as adverse event reporting, safety corrective actions, and product recalls
- Perform any ad-hoc duties when required.
Requirements:
- Min Degree in Life Sciences/ Biotechnology / Chemistry, or related discipline
- Min5 years of regulatory affairs experience within medical devices
- Strong understanding of regulatory submission processes and compliance frameworks
- Familiarity with ISO 13485 and GDPMDS would be advantageous.
Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.
We regret that only shortlisted candidate will be notified.
Email:
Recruitpedia Pte. Ltd.
EA License No. 19C9682
EA Reg. No. R (Lai Hor Yan)
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Job Description
(Job ID: )
Responsibilities:
- Draft, review, and negotiate contracts, agreements, and other legal documents supporting local and regional operations.
- Provide legal advice on corporate, commercial, and regulatory matters.
- Support compliance initiatives, including antitrust, anti-corruption, and data protection requirements.
- Assist in managing litigation, arbitration, and dispute resolution matters.
- Collaborate with internal stakeholders and external legal counsel to identify and mitigate legal risks.
- Monitor regulatory developments and advise on their impact on business operations.
Requirements:
- Admission to the Singapore Bar.
- Minimum 3–5 years of relevant legal experience in a law firm or in-house legal function, preferably within an international business environment.
- Strong knowledge of contract law and regulatory compliance frameworks.
- Knowledge of maritime law, trade compliance (including economic sanctions), mergers and acquisitions, or industry-specific regulations is an added advantage.
- Experience working in Japanese company.
To Apply, please kindly email your updated resume to
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We regret that only shortlisted candidates will be notified. However, rest assured that all applications will be updated to our resume bank for future opportunities.
EA Personnel Name: Gary Ho Cheng Xuan
EA Personnel Reg. No.: R
EA License No.: 07C5771
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Job Description
Company Overview:
Our client is a leading international specialist law firm with a strong presence across Asia-Pacific, Europe, the Americas, the Middle East, and Africa, with more than 40 offices worldwide.
Job Summary:
As a Legal Secretary, you will be providing key administrative support to a team of lawyers in the Litigation practice. The candidate that will thrive in this role is someone who is independent, dynamic, and enjoys a fast-paced and detail-oriented environment - while being able to pick things up quickly and maintain impeccable professionalism in their work.
Key Responsibilities
- Provide secretarial support, including scheduling appointments, travels, submitting expense claims, and screening all incoming and outgoing communications.
- Prepare, format, and proofread litigation documents, including pleadings, affidavits, submissions, court forms, and correspondence.
- Manage court deadlines and coordinate court filings, hearings, and communications with court officials.
- Prepare court bundles and hearing materials, and arrange the filing and service of court documents.
- Assist lawyers with the billing process, including drafting pre-bills, editing narratives, and finalising bills.
- Handle legal administrative tasks, including opening and closing files, maintaining document databases, formatting legal documents, and ensuring accurate record management.
Requirements
- Proven experience as a Legal Secretary, with 7–12 years in a reputable law firm. Prior experience in litigation or disputes is highly preferred.
- Exemplary spoken and written communication skills. Please note that the ability to speak Mandarin is highly advantageous so as to communicate with regional offices.
- Proficiency in handling legal documentation, and a familiarity with local court processes is preferred.
- Organised, efficient and able to work independently in an fast-paced environment, with the resources to resolve issues as quickly as they arrive.
- Exceptional professional conduct and ability to handle communications discreetly while maintaining confidentiality.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. By submitting your application, you give us permission to store and use your data for recruitment purposes in accordance with our privacy policy.
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Job Description
An international law firm is looking to hire an associate/senior associate for their Tier 1 IP and TMT team. You will work on both contentious and non-contentious matters in the IP and tech industry, including IP infringement, international prosecution strategies, domain name disputes and border enforcement. On the contentious-front, you will be advising on IP-related commercial arises arising from M&A, restructuring, cybersecurity and audits. Their clients are some of the world's best known brands and the work will be exciting.
Requirements:
- Strong Academic Qualifications. Having been on the Dean's List, obtaining Distinction for your Part B examinations, or significant Mooting experience will be advantageous.
- Singapore Qualified (1-6 PQE)
- Strong background in disputes, ideally from one of the local big 4 law firms or a strong disputes boutique firm
- The partner is keen on hiring/retooling those from AGC/JLC backgrounds
- Prior experience with IP/TMT matters such as is advantageous but not necessary if you are able to demonstrate a strong interest in IP
- You have strong technical, drafting and commercial skills.
If you are keen on exploring this role, do apply! We regret that only shortlisted applicants will be contacted.
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Job Description
UNIQLO is a leading brand of the Fast Retailing Group, one of the largest apparel retailers in the world. UNIQLO respects the individuality and lifestyle of our customers and takes pride in creating simple, high quality and highly functional everyday clothing designed to make everyone’s daily life better. At the heart of our business are our stores – where customers can experience firsthand the quality, comfort and innovation of our products.
The Legal Department plays a critical role in enabling the successful finalisation of all store leases in Singapore. We work closely with internal stakeholders to balance commercial objectives with sound legal risk management, to ensure that the company’s interests are safeguarded without impeding business growth.
We are seeking an experienced leasing lawyer to join us on a 1-year contract. This role will support the Legal Department in the review, negotiation, and execution of store leases across Singapore. The successful candidate will also be required to support the Legal Department on other legal matters as required from time to time, including but not limited to commercial contract reviews, general legal advisory work, research and regulatory and compliance matters.
Key Responsibilities
- Lead and support the review, negotiation and finalization of letters of offer, store leases, construction, renovation, maintenance and all other related agreements stores across Singapore.
- Drive consistency in key agreements (especially leases) and ensure adherence to internal global and local policies and guidelines
- Provide practical, risk-based legal advice to internal stakeholders, balancing commercial considerations with legal safeguards
- Identify, analyse, and mitigate legal and operational risks associated with all agreements and negotiations, especially lease terms and landlord negotiations
- Work closely with cross-functional teams (especially with store development, store design and finance teams) to ensure timely negotiation and execution of agreements that adequately protect the company’s interest
- Support the Legal Department on other legal matters as required, including but not limited to commercial contract reviews, general legal advisory work, research and regulatory and compliance matters
Requirements
- Bachelor’s Degree in Law
- Admitted to the Singapore Bar or another common law jurisdiction
- 4 to 7 years of post-qualification experience, with a strong focus on real estate and leasing matters
- Demonstrated experience in commercial retail leasing, with familiarity in negotiating and reviewing complex retail lease agreements
- Excellent drafting, negotiation, and stakeholder management skills with the ability to effectively engage and influence cross-functional stakeholders (including store development, store design and finance teams)
- Strong commercial acumen, with the ability to understand operational and commercial objectives, assess legal risks in context, clearly articulate options and trade-offs, and provide balanced, pragmatic recommendations
- Proven ability to organize, prioritise and manage multiple matters independently in a fast-paced environment
- Strong analytical and problem-solving skills with attention to detail
- High level of integrity, professionalism and sound judgment
Pay Range: $7,800 - $8,200.
Why Join Us
You will be part of a collaborative Legal Department that plays a strategic role in anchoring UNIQLO’s retail presence in Singapore. This role offers valuable exposure to the retail industry and the opportunity to partner closely with cross-functional teams in a fast-paced, commercially driven environment.
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Job Description
Cana Consulting is partnering with a client who is seeking an experienced Legal Secretary to support a senior Partner with a busy disputes and international arbitration practice. This is an excellent opportunity to work on complex, cross-border matters in a fast-paced and collaborative environment.
Key Responsibilities
- Provide comprehensive secretarial and administrative support to the Partner.
- Manage calendars, meetings, travel arrangements and diary commitments.
- Prepare, format and proofread legal documents, correspondence and presentation materials.
- Coordinate court and arbitration filings, hearing bundles and matter documentation.
- Maintain matter files and monitor key deadlines.
- Liaise with clients, external counsel and internal stakeholders.
- Assist with billing, time entries, expenses and general practice administration.
- Support business development and other ad hoc administrative matters as required.
Requirements
- Prior experience as a Legal Secretary in a law firm.
- This position requires someone who has experience working as a Legal Secretary/PA for executive
- Ability to regulate stress and has good sense of judgment, as well as details to attention
- Experience supporting litigation, disputes or arbitration practices is preferred.
- Strong organisational and multitasking skills with excellent attention to detail.
- Proficient in Microsoft Office, particularly Word and Outlook.
- Strong communication skills and the ability to work effectively in a fast-paced environment.
EA Lic: 24S2202 | CEI Reg: R
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