Regulatory Affairs Specialist

Andaman Medical; Philippines; On-site; PHP 700,000 - 1,200,000; Full time

Job summary

Andaman Medical in the Philippines is seeking a Regulatory Affairs Lead to guide product registration and ongoing compliance for medical devices, foods, and cosmetics. You will develop strategies, advise on classifications, and ensure timely approvals across multiple markets.

The role requires strong regulatory writing, stakeholder management, and cross-functional collaboration to support post-market activities and ongoing regulatory updates.

Qualifications

• Bachelor’s Degree, Post-Graduate Diploma, Professional Degree in Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent.
• Licensed Pharmacist preferred.
• Minimum of 3–5 years of Regulatory Affairs experience.
• Experience with Medical Device, Food/Food Supplements, and Cosmetics regulatory categories.
• Strong regulatory writing and documentation skills.
• Excellent communication and stakeholder management abilities.

Responsibilities

• Serve as the regulatory lead for assigned clients and provide regulatory consultation throughout the product lifecycle.
• Develop regulatory strategies based on country-specific requirements and business objectives.
• Advise clients on product classification, regulatory pathways, documentation requirements, and market entry strategies.
• Conduct gap assessments of technical documentation and provide recommendations for regulatory compliance.
• Interpret and communicate regulatory requirements to both internal teams and external clients.
• Manage end-to-end regulatory submissions for healthcare products, including medical devices, food and cosmetics.
• Prepare, review, and compile regulatory dossiers; verify completeness of submission documents.

Skills

Regulatory writing

Stakeholder management

Project management

English proficiency

Education

Bachelor’s degree or equivalent

Licensed Pharmacist (preferred)

Tools

Microsoft Office

Job description

• Serve as the regulatory lead for assigned clients and provide regulatory consultation throughout the product lifecycle.
• Develop regulatory strategies based on country-specific requirements and business objectives.
• Advise clients on product classification, regulatory pathways, documentation requirements, and market entry strategies.
• Conduct gap assessments of technical documentation and provide recommendations for regulatory compliance.
• Interpret and communicate regulatory requirements to both internal teams and external clients.

Product Registration

• Manage end-to-end regulatory submissions for healthcare products, including medical devices, food and food supplements, and cosmetics, (where applicable). Responsibilities include, but are not limited to, product registrations, license renewals, change notifications and variations, product classification, label and claims review, post-market reporting, and ensuring compliance with applicable regulatory requirements.

Regulatory Submission Management

• Prepare, review, and compile regulatory dossiers.
• Verify completeness and accuracy of submission documents.
• Coordinate legalization, notarization, and certification of regulatory documents where applicable.
• Submit applications through electronic regulatory systems and government portals.
• Track submission progress and respond to deficiency letters within stipulated timelines.
• Coordinate with regulatory authorities to facilitate approval.

Client Management

• Act as the primary point of contact for assigned clients.
• Conduct regulatory consultation meetings.
• Provide regular project status updates.
• Provide regular project status updates.
• Prepare regulatory timelines and project plans.
• Respond to client inquiries regarding regulatory requirements.
• Maintain strong professional relationships with clients.
• Monitor regulatory changes across assigned markets.
• Analyze new regulations and assess their impact on clients.
• Prepare regulatory update reports and client advisories.
• Maintain internal regulatory databases and guidance documents.
• Conduct regulatory research for new markets.

Post-Market Regulatory Compliance

• Coordinate change notifications and variations
• Support PMS activity reporting (FSCA, FSN, Adverse event, Product Recall)
• Support complaint investigations from a regulatory perspective

Cross-functional Collaboration

• Work closely with Business Development, Operations, Logistics, Quality Assurance, Finance and Legal.

Documentation & Quality Management

• Maintain accurate regulatory records.
• Ensure compliance with internal SOPs and quality management procedures.
• Support ISO 9001 / ISO 13485 documentation requirements.
• Participate in internal and external audits.

Qualifications & Experience

• Bachelor’s Degree, Post-Graduate Diploma, Professional Degree, Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent.
• Preferably a Licensed Pharmacist
• Minimum of 3-5 years of Regulatory Affairs experience.
• Hands on experience on the following regulatory product categories: Medical Device, Food/Food Supplements, and Cosmetics.
• Experience managing multiple client projects simultaneously is preferred.
• In-depth understanding of Philippine regulatory framework on medical device, food/food supplements, and cosmetics.
• Strong regulatory writing and documentation skills.
• Excellent communication and stakeholder management abilities.
• High attention to detail and ability to manage multiple regulatory projects.
• Proficient in English (written and spoken).
• 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.).

Preferred Qualifications

• Able to operate in a multicultural environment.
• Customer-oriented with a consultative mindset.
• High level of autonomy at work, yet with profound team-spirit.
• Proactive, adaptable, and committed to continuous learning in a rapidly evolving regulatory environment.