262 Regulatory Affairs Specialist jobs in Singapore

The Compliance Specialist role offers a great opportunity to work in the medical devices industry, ensuring product compliance with quality and regulatory requirements throughout development and transfer to production.

• Supports procedures to ensure compliance with Quality Systems and industry regulations during product development, maintaining an up-to-date Quality Management System aligned with current regulations.
• Collaborates with cross-functional teams and specification consultants to coordinate regulatory information, educating teams on Quality System requirements and conducting training sessions.

• Monitors and communicates updates on relevant regulations affecting product specifications, including efficacy and stability data, design history and development, technical construction documentation, risk management and clinical evaluation.
• Leverages expertise to establish and manage Technical Files for low to high-risk medical devices.

• Minimum 2 years of Quality and Regulatory experience in Medical or Pharmaceutical industry, with a good understanding of US, EU, HSA, and other regulations.
• Excellent communication skills for interacting with Health Authorities and Authorised Agencies.
• Internal Audit experience with knowledge of Singapore, Asia Pacific, and European regulatory requirements.

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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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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Job title: Regional Regulatory Affairs Specialist

Reference ID: 36639

Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regional Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring activities across local affiliates.

You will be reporting to the eam Leader (Singapore).

【 Responsibilities 】

- Regulatory coordination with local Responsible Persons

- Documentation & dossier management (ASEAN CTD, eCTD)

- Compliance oversight & regulatory intelligence

- Stakeholder engagement across multiple internal teams

- Lifecycle management and post-approval changes

- Electronic submission systems / regulatory tracking tool usage

【 What you will receive 】

- AWS

- Variable Bonus (Depends on Company and Individual performance)

- Annual Leave 14 days

- Medical Leave

- Medical Benefits

- Flexible Benefits (S$1500/year)

- WFH: Once a week to be at Office, others day WFH

【Requirements & Preferences】

(Must)

- Bachelor's or Master's in Pharmacy, Life Sciences, or related field

- Minimum 3 years of experience in Regulatory Affairs within Singapore's pharmaceutical industry.

- Familiarity with ASEAN CTD, ICH, country-specific regulations

- Proficiency in both written and spoken English is required to liaise with counterparts and handle documentation.

- Proactive, self-motivated, and able to take initiative with high energy levels.

(Advantageous)

- Possess regional exposure in APAC

- Strong communication and negotiation skills.

- Logical thinking and sound problem-solving capabilities.

- Ability to adapt well to changes and work effectively under pressure.

- Possess regional experience in a large pharmaceutical company is an advantage.

We regret that only shortlisted candidates will be notified.

Registration No.: R Stanley Neo Khay Liang)

Recruitment Licence: 12C5051

Regulatory Affairs Specialist – Biotechnology
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
As a Biotechnologist at Lonza Mammalian business, you’ll be part of our globally recognized network, driving the production of mammalian cell culture and treatments.
Join our best-in‐class high performance Integrated Biologics team at our Tuas site in Singapore to gain unparalleled exposure to cutting‐edge biotechnology and innovation and make a difference from day one. Learn new skills and capabilities. Grow your career with us in manufacturing therapeutic proteins under cGMP conditions. Find out more about what a life at Lonza in Singapore could look like for you by watching this short video.
What you’ll get:
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Daily company bus from the MRT location near your home to and from the Tuas site.
Fully paid medical insurance, with the option to enroll family members at partially subsidized premiums.
The full list of our global benefits can be also found on
What you’ll do:
Perform GMP manufacturing operations, equipment handling, and troubleshooting.
Maintain facility and lab standards through sanitization and 6S housekeeping.
Apply aseptic techniques for material and cell culture handling.
Operate bioreactors, monitoring pH/DO, CO2/O2, and cell performance.
Execute chromatography, ultrafiltration, and pH/conductivity adjustments.
Utilize process control systems (UNICORN, DeltaV) and documentation (SOPs, logbooks, BRs).
Handle single‐use technologies and sample submissions via LIMS.
Prepare customer‐specific solutions and set up equipment for operations (CIPs, buffer transfer).
Plan and execute CIPs (downstream), ensuring correct pathways and configurations.
What we’re looking for :
Degree or diploma in a related Science/Engineering field.
Knowledge of Biopharmaceutical processing is an added asset.
Relevant work experience in a similar manufacturing industry or cleanroom environment preferred.
Knowledge of cGMP applications.
Positive team oriented demeanor.
Strong communication and interpersonal skills.
Willing to perform a rotating 12‐hour shift pattern.
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Job title: Regional Regulatory Affairs Specialist
Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regional Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring activities across local affiliates.
You will be reporting to the Team Leader (Singapore).
Responsibilities
Regulatory coordination with local Responsible Persons
Documentation & dossier management (ASEAN CTD, eCTD)
Compliance oversight & regulatory intelligence
Stakeholder engagement across multiple internal teams
Lifecycle management and post-approval changes
Electronic submission systems / regulatory tracking tool usage
What you will receive
AWS
Variable Bonus (Depends on Company and Individual performance)
Annual Leave 14 days
Medical Leave
Medical Benefits
Flexible Benefits (S$1500/year)
WFH: Once a week to be at Office, others day WFH
Requirements & Preferences
(Must)
Bachelor’s or Master’s in Pharmacy, Life Sciences, or related field
Minimum 3 years of experience in Regulatory Affairs within Singapore's pharmaceutical industry.
Familiarity with ASEAN CTD, ICH, country-specific regulations
Proficiency in both written and spoken English is required to liaise with counterparts and handle documentation.
Proactive, self-motivated, and able to take initiative with high energy levels.
(Advantageous)
Possess regional exposure in APAC
Strong communication and negotiation skills.
Logical thinking and sound problem-solving capabilities.
Ability to adapt well to changes and work effectively under pressure.
Possess regional experience in a large pharmaceutical company is an advantage.
We regret that only shortlisted candidates will be notified.
#J-18808-Ljbffr

Job title: Regional Regulatory Affairs Specialist
Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regional Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring activities across local affiliates.
You will be reporting to the eam Leader (Singapore).
Responsibilities
Regulatory coordination with local Responsible Persons
Documentation & dossier management (ASEAN CTD, eCTD)
Compliance oversight & regulatory intelligence
Stakeholder engagement across multiple internal teams
Lifecycle management and post-approval changes
Electronic submission systems / regulatory tracking tool usage
Benefits
AWS
Variable Bonus (Depends on Company and Individual performance)
Annual Leave 14 days
Medical Leave
Medical Benefits
Flexible Benefits (S$1500/year)
WFH: Once a week to be at Office, others day WFH
Requirements (Must)
Bachelor’s or Master’s in Pharmacy, Life Sciences, or related field
Minimum 3 years of experience in Regulatory Affairs within Singapore's pharmaceutical industry.
Familiarity with ASEAN CTD, ICH, country-specific regulations
Proficiency in both written and spoken English is required to liaise with counterparts and handle documentation.
Proactive, self-motivated, and able to take initiative with high energy levels.
Advantageous (Optional)
Possess regional exposure in APAC
Strong communication and negotiation skills.
Logical thinking and sound problem-solving capabilities.
Ability to adapt well to changes and work effectively under pressure.
Possess regional experience in a large pharmaceutical company is an advantage.
We regret that only shortlisted candidates will be notified.
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Your new company

Join our client to be part of their international team as a Regional Regulatory Affairs Specialist, where your expertise in APAC regulations and cross-functional collaboration will drive impactful healthcare solutions across diverse markets.

Your new role

You will be instrumental in managing regulatory operations across international markets. Based in Singapore, you will work closely with local affiliates and their designated Responsible Persons to ensure the timely and compliant execution of product registrations, renewals, and post-approval changes. Your role will involve preparing and overseeing regulatory documentation—including ASEAN CTD and eCTD formats—while ensuring alignment with evolving regional requirements. You will also maintain accurate records using electronic submission systems and tracking tools. In addition, you will collaborate with cross-functional teams such as CMC, Support & Promotion, Labelling, Business, Quality Assurance, and Pharmacovigilance to ensure regulatory alignment and contribute to strategic planning through regulatory intelligence and competitor insights.

What you'll need to succeed

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related discipline.
• Minimum of 3 years of hands-on experience in regulatory affairs within the pharmaceutical industry, ideally with regional exposure across APAC markets.
• Solid understanding of APAC regulatory frameworks, including ASEAN CTD, ICH guidelines, and country-specific requirements.
• Proven ability to manage multiple priorities and collaborate effectively with internal teams and external partners on regulatory matters.
• Solid interpersonal and communication abilities, with a detail-oriented and structured approach to documentation and compliance.

What you'll get in return

• Play a key role in shaping regulatory strategies across diverse international markets, driving access to healthcare solutions globally.
• Work closely with dynamic teams across Regulatory, Quality, Business, and Pharmacovigilance to influence strategic decisions.
• Expand your expertise in APAC regulatory frameworks while managing end-to-end submissions and lifecycle activities in a fast-paced, multicultural environment.

What you need to do now

If you feel like you meet the above requirements or know someone who does, then click on the link to apply, or, you may send your application/referral directly to me at

EA Reg Number: R

EA License Number: 07C3924 | Company Registration No: D

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.

What you will do:

Quality Assurance (QA)

• Handle and manage local annual GDPMDS and GDP inspection; support inspection readiness
• Maintain and manage all controls of documents and records
• Manage and maintain local GDPMDS and GDP SOP and system records, including but not limited to all product complaints, returns, disposal, internal inspection/ audit, deviation,CAPA management, etc
• Manage new and existing supplier management activities
• Perform personnel training to ensure regulatory and quality compliance

Regulatory Affairs & Pharmacovigilance (RA & PV)

• Manage and process AE intake for all products
• Perform signal detection
• Manage compliance of all PV SOPs
• Provide regulatory support in RA activities

You are someone who:

• Holds a Bachelor's degree in Life Sciences, Pharmacy, or a related discipline
• Has at least 2 years of experience in pharmaceutical or medical device QA or RA, with some exposure to PV
• Is familiar with Singapore HSA regulations, including Health Supplements Guidelines, Medical Device Regulations, and GDP
• Has experience in SOP writing, inspection preparation, and Quality Management Systems (QMS)
• Demonstrates strong documentation, regulatory filing, and communication skills
• Is eager to grow with the company and open to cross-functional learning and development
• Is ready to take on more responsibilities within the Quality & Regulatory Affairs domain; training and mentorship provided
• Is adaptable and willing to support the team with ad hoc tasks when required.

It's a bonus if you also have:

• Knowledge or exposure to US FDA biologic regulations and pharmacovigilance systems
• Experience in SME distribution companies or startup environments
• Experience in preparing for inspection readiness

What we offer:

• Competitive salary and performance-based bonuses
• Opportunities for professional growth and development
• Coffee treats from our generous bosses
• A team of hard-working colleagues who work hard and play hard