The Senior Regulatory Affairs Manager is responsible for leading and managing all regulatory activities to ensure compliance with Philippine regulatory requirements for pharmaceutical products including generics, biosimilars, and new chemical entities. The role oversees regulatory submissions, product registrations, lifecycle management, and regulatory strategy while coordinating with internal departments and regulatory authorities.
The position requires deep knowledge of pharmaceutical regulatory frameworks and strong engagement with industry organizations such as the Philippine Pharmacists Association (PPhA), Philippine Association of Pharmacists in Pharmaceutical Industry (PAPPI), and Industrial Pharmacists Association of the Philippines (IPAP).
Key Responsibilities
I. Regulatory Strategy and Compliance
- Develop and implement regulatory strategies for pharmaceutical products including generics, biosimilars, and new drugs.
- Ensure compliance with Philippine regulatory requirements and industry standards.
- Lead regulatory submissions for product registration, variation applications, and renewals.
II. Product Registration and Lifecycle Management
- Prepare, review, and submit regulatory dossiers and technical documents.
- Manage regulatory timelines for product approvals and post-approval changes.
- Oversee regulatory lifecycle management activities for marketed products.
III. Regulatory Authority Liaison
- Serve as the primary point of contact with regulatory authorities such as the Philippine Food and Drug Administration.
- Coordinate regulatory meetings, responses to agency queries, and inspections.
- Monitor regulatory changes and provide guidance to internal teams.
IV. Cross-Functional Collaboration
- Work closely with Quality Assurance, Manufacturing, Pharmacovigilance, Medical Affairs, and Commercial teams.
- Provide regulatory guidance for product development and commercialization.
- Support clinical development and market access activities where applicable.
- Leadership and Team Management
- Lead and mentor regulatory affairs staff.
- Ensure regulatory team productivity, compliance, and professional development.
- Promote continuous improvement in regulatory processes and documentation.
VI. Industry Engagement
- Maintain active engagement with professional pharmacy organizations such as:
a) Philippine Pharmacists Association (PPhA)
b) Philippine Association of Pharmacists in Pharmaceutical Industry (PAPPI)
c) Industrial Pharmacists Association of the Philippines (IPAP)
Qualifications
- Bachelor's degree in Pharmacy (Registered Pharmacist preferred).
- Master's degree in Regulatory Affairs, Pharmaceutical Sciences, Public Health, or related field is an advantage.
- Minimum of 12 years of experience in the pharmaceutical industry.
- Extensive experience handling regulatory activities for:
a) Generic medicines
b) Biosimilars
c) New drugs / innovative products
- Proven experience managing regulatory submissions and approvals.
- Candidates who are active members of one or more of the following organizations are strongly preferred:
a) Philippine Pharmacists Association (PPhA)
b) Philippine Association of Pharmacists in Pharmaceutical Industry (PAPPI)
c) Industrial Pharmacists Association of the Philippines (IPAP)
Skills and Competencies
- Strong knowledge of Philippine pharmaceutical regulatory requirements.
- Expertise in drug registration, dossier preparation, and lifecycle management.
- Extensive experience with Philippine regulatory requirements, including preparation and submission of dossiers in the ASEAN Common Technical Dossier (ACTD) format.
- Excellent leadership, communication, and stakeholder management skills.
- Strong analytical and problem-solving abilities.
