631 Regulatory Affairs Specialists jobs in Singapore

Job title: Regulatory Affairs Specialist

Reference ID: 36639

Our client, a Japanese pharmaceutical company, is currently seeking to hire a 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 Regulatory Affairs Department in Japan.

【 Responsibilities 】

‐ Handle mainly regulatory operations tasks

- Report directly to the Regulatory Affairs Department in Japan

- Coordinate regulatory submissions (new and variation) across Asia/ASEAN

- Manage regulatory documents and ensure timely submissions

- Develop regulatory strategies with cross-functional teams

- Track and monitor local affiliate regulatory activities

- Identify and resolve regulatory issues proactively

【 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)

- Diploma in any discipline.

- Minimum 2 years of experience in Regulatory Affairs within Singapore's pharmaceutical industry.

- 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)

- 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 Yeo Ker Ling Caroline)

Recruitment Licence: 12C5051

• 1510
• SINGAPORE, Singapore
• Market Access
• APAC
• Permanent
• Hybrid

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.

• 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.

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.

We 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.

• 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

• 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.

• 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, labelling, 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 both English and Chinese is a requirement. We have clients all over the world.
• 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

• 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.

About the Role

As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and company policies. You will work closely with various departments to ensure that all aspects of our business are in line with relevant regulations.

Key Responsibilities

• You will be the designated compliance officer for Singapore, US, and Cayman regulations, ensuring adherence to both group compliance procedures and compliance regulations.
• You will own, oversee, and enforce the Compliance Manual and Code of Ethics across the NY and Singapore offices.
• You will ensure timely compliance with regulations and reporting requirements, collaborating with Operations, Product Control, HR, and other functions.
• You will coordinate with local regulators, compile and distribute monthly compliance reports, and conduct periodic reviews of existing client portfolios.
• You will assist in preparing and reviewing annual mandatory returns/reports for submission to local authorities and conduct gap analyses between regulatory requirements and current processes.
• You will develop, review, update, implement, and conduct training programs on onboarding of Portfolio Managers and anti-money laundering and specific compliance measures.
• You will provide daily support and guidance on compliance matters, particularly regarding KYC documents, to the administration team.
• You will review client onboarding documents to ensure compliance with ACRA regulations and internal policies, follow up on outstanding or missing KYC/compliance documents, and conduct periodic compliance reviews.

What We Offer

We offer a dynamic work environment where you can lead, grow, and develop your skills. Our company values integrity, accountability, and long-term thinking. As a member of our team, you will gain strategic impact, leadership autonomy, cross-functional collaboration, and growth opportunities.

Requirements

• You should have strong knowledge of compliance regulations and company policies.
• You should have excellent communication and interpersonal skills.
• You should be able to work independently and as part of a team.

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.

We 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.

• 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, labelling, 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 both English and Chinese is a requirement. We have clients all over the world.
• 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

• 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.

We are seeking a seasoned Compliance Manager to spearhead our compliance function, ensuring all operations and business activities adhere to regulatory requirements and internal policies.

• Oversee compliance across multiple businesses in Singapore and Malaysia.
• Develop and implement effective compliance strategies, including monitoring, governance, and reporting.
• Lead company projects and initiatives involving regulatory compliance.
• Stay abreast of key regulatory changes and advise relevant business divisions on their impact.
• Provide regulatory advice to the organization.
• Participate in compliance risk assessments, reporting, reviews, testing, and provide compliance comments/advisory.
• Update compliance-related documents to reflect latest rules and regulations, industry best practices, and changes to MAS regulations, data protection laws, etc.
• Build and develop compliance policies, including AML/CFT Sanctions Policy, Data Protection Policy, and Anti-Corruption &Bribery Policy.
• Conduct regular and timely compliance training for staff.
• Communicate with key stakeholders, including regulators, auditors, vendors, etc.

About You:

• A minimum of 5 years of experience in compliance or related functions.
• Knowledge and understanding of financial markets.
• Familiarity with Singapore regulations and requirements.
• Experience working for a smaller fintech or startup.
• Detail-oriented with the ability to multitask and meet deadlines with minimal supervision.
• Strong team player with excellent interpersonal skills.
• Keen interest and understanding in cryptocurrency, blockchain technology, and digital assets.
• Quality-focused with a passion for continuous improvement in process and procedures.

Our international client is expanding its operations in Singapore, and we are seeking a skilled Compliance Manager to oversee their compliance function.

Job Responsibilities:

• Conduct thorough due diligence on clients and perform KYC checks in accordance with regulatory standards and company policies.
• Ensure adherence to applicable statutory rules, regulations, MAS notices, and guidelines by reviewing key aspects of the company's operations.
• Develop, review, and update internal compliance policies and procedures to guarantee alignment with regulatory changes.
• Educate and train employees on regulatory compliance, AML/CFT requirements, and updates in relevant policies and procedures.
• Resolve compliance-related questions and queries from authorities, management, and colleagues.

Requirements:

• Bachelor's Degree or Diploma.
• Relevant certification in compliance, risk, and governance (bonus).
• Relevant certification in AML/CFT (bonus).
• At least 4 years of experience in compliance within a financial services environment, preferably in a capital markets-focused firm.

• 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, labelling, 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 both English and Chinese is a requirement. We have clients all over the world.
• 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

• 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.