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Open nowFirst seen 5 days ago

Regulatory Affairs Department Head (Pharmaceutical)

HRTX1,628 open roles

Where
Santa Maria, Laguna, Philippines
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Your applicationOpen nowRegulatory Affairs Department Head (Pharmaceutical)HRTX · Santa Maria, Laguna, Philippines

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: first seen 5 days ago

The posting

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
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