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