Regulatory Affairs Department Head

5 days ago

Santa Maria, Philippines HR TechX Corp. Full time

Regulatory Affairs Department Head (Pharmaceutical) Location: Laguna Work Schedule: Monday to Friday, 8:00 AM to 5:00 PM Set Up: Onsite role About The Role The Regulatory Affairs Department Head will oversee all regulatory submissions, renewals, and compliance initiatives for both local and export markets. You will manage a small team, guide regulatory strategy, and collaborate closely with cross‑functional departments to ensure timely and accurate documentation. This role plays a critical part in ensuring the organization meets all regulatory standards while supporting client requirements and maintaining up-to-date knowledge of industry regulations. Key Responsibilities Lead the regulatory team in managing product registrations, renewals, and compliance activities. Review and approve technical dossiers for local and international submissions. Coordinate with Technical Services, QA, QC, Formulation, Marketing, and other internal groups to ensure complete documentation. Liaise with regulatory agencies and client regulatory counterparts. Monitor regulatory changes and provide updates to internal stakeholders. Serve as the Pharmacovigilance Officer and ensure adherence to reporting requirements. Maintain updated databases of regulatory documentation and regional requirements. Leadership Responsibilities Direct management of a Regulatory Affairs Manager, Regulatory Affairs Associate, and Company Pharmacist. Oversight of an indirectly supervised Technical Clerk. Work under general supervision of the R&D/Regulatory Division leadership. Qualifications Licensed Pharmacist with a degree in Pharmacy or Industrial Pharmacy. Minimum of 5 years of experience in regulatory affairs or product registration within manufacturing (pharmaceutical, food, or cosmetics preferred). Strong understanding of FDA regulations and other government regulatory frameworks. Knowledge of GMP, ISO 9001:2015 basics, EHS, QMS, and licensing processes. Excellent attention to detail, documentation skills, and communication abilities. Proficiency in basic computer applications. Additional Skills Strong problem‑solving and decision‑making capability Root cause analysis Project management Customer service orientation Performance management Working Environment Clean, well‑organized office setup Hybrid of desk work and occasional field activities Collaboration with internal teams and external regulatory bodies Seniority Level Not Applicable Employment Type Full‑time Job Function Legal Industries Technology, Information and Internet #J-18808-Ljbffr

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