Regulatory Affairs Department Head (Pharmaceutical)

  • Santa Maria, Laguna, Philippines
  • Full-Time
  • On-Site
Apply now Refer
Job Description:
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