Regulatory Affairs Manager
Regulatory Affairs Manager
Alpha-Pharma Healthcare is expanding its regulatory operations across South East Asia and is seeking an experienced Regulatory Affairs Manager to lead and strengthen our pharmaceutical product registration activities in the Philippines.
This role offers an exciting opportunity to take a leadership position within a dynamic international environment, driving regulatory strategy, ensuring compliance excellence, and contributing directly to bringing high-quality pharmaceutical products to market while engaging with global manufacturing partners and local regulatory authorities.
Key Responsibilities- Lead and oversee pharmaceutical product registration activities in the Philippines and selected South East Asian markets
- Review and assess quality and GMP documentation from manufacturing sites
- Oversee compilation, review, and gap analysis of CTD/ACTD dossiers (Modules 1–3)
- Ensure timely preparation and submission of regulatory dossiers to the Philippine FDA
- Lead the drafting, review, and coordination of responses to regulatory deficiency letters
- Support and guide suppliers with ASMF submissions for applicable dossiers
- Maintain company LTO and manage regulatory compliance obligations
- Act as the primary liaison with local regulatory authorities to ensure smooth and efficient registration processes
- Provide regulatory guidance internally and support cross-functional coordination
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm) or Chemistry (B.Sc/M.Sc)
- 5–8 years of experience in Regulatory Affairs and/or Quality Assurance within the pharmaceutical industry
- Strong practical knowledge of Philippine FDA regulatory requirements
- Experience with eCTD compliance and publishing preferred
- Solid understanding of Quality Management Systems (QMS) and Good Distribution Practice (GDP)
- Demonstrated ability to liaise effectively with regulatory authorities
- Strong communication and leadership skills with professional English proficiency
- Valid pharmacist licence preferred
Why Join Alpha-Pharma Healthcare?
You will become part of a growing regional organization committed to regulatory excellence, quality compliance, and expanding patient access to essential medicines across South East Asia. This leadership role provides exposure to international regulatory standards, cross-border collaboration, strategic responsibility, and meaningful career development opportunities.