Autonomy-Driven Regulatory Affairs Specialist

ANDAMAN MEDICAL PHILIPPINES CORPORATION; Las Piñas; On-site; PHP 600,000 - 900,000; Full time

Job summary

ANDAMAN MEDICAL PHILIPPINES CORPORATION is seeking a Regulatory Affairs Specialist to drive regulatory strategies, lead client engagements, and manage end-to-end submissions for medical devices, foods, cosmetics, and related products. The role emphasizes autonomy in regulatory planning, dossier preparation, and cross-functional collaboration.

The ideal candidate has 3–5 years of regulatory experience, strong writing skills, and is proficient in English.

Qualifications

• Bachelor’s Degree or higher in a relevant field (Biology, Chemistry, Pharmacy/Pharmacology, etc.).
• Licensed Pharmacist preferred.
• Minimum 3–5 years Regulatory Affairs experience.
• Experience with Medical Device, Food/Food Supplements, and Cosmetics regulatory products.
• Experience managing multiple client projects.

Responsibilities

• Serve as 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.
• Prepare, review, and compile regulatory dossiers and verify completeness of submission documents.
• Coordinate legalization, notarization, and certification of regulatory documents.
• Submit applications through electronic regulatory systems and government portals.
• Track submission progress and respond to deficiency letters within deadlines.
• Coordinate with regulatory authorities to facilitate approval.
• Act as the primary point of contact for clients and conduct regulatory consultation meetings.
• Prepare regulatory timelines and project plans.
• Monitor regulatory changes across assigned markets and prepare update reports.

Skills

Regulatory writing

Documentation

Stakeholder management

Attention to detail

English proficiency

Office suite

Education

Bachelor’s Degree

Post-Graduate Diploma

Professional Degree

Biology

Chemistry

Pharmacy/Pharmacology

Biotechnology

Equivalent

Tools

Microsoft Office

Job description

ANDAMAN MEDICAL PHILIPPINES CORPORATION is seeking a Regulatory Affairs Specialist to drive regulatory strategies, lead client engagements, and manage end-to-end submissions for medical devices, foods, cosmetics, and related products. The role emphasizes autonomy in regulatory planning, dossier preparation, and cross-functional collaboration.

The ideal candidate has 3–5 years of regulatory experience, strong writing skills, and is proficient in English.