Regulatory Affairs Department Head (Pharma)

Location: Canlubang, Laguna

Setup: Full onsite

Schedule: Monday to Friday, 8am-5pm

Role Overview

This role leads a small Regulatory Affairs team to ensure timely and accurate preparation, submission, and renewal of product registrations, licenses, and regulatory dossiers. It supports strategic directions set by the Regulatory/R&D leadership and ensures full compliance with local and international regulatory requirements. The position also works closely with internal departments, clients, and government agencies to facilitate smooth and efficient product registration processes.

Qualifications

• Bachelors degree in BS Pharmacy or BS Industrial Pharmacy
• Must be a licensed pharmacist
• At least 5 years of relevant experience in product registration within a manufacturing environment, ideally in pharmaceuticals, food, or cosmetics
• Strong familiarity with FDA regulations and other government regulatory requirements
• Proficient in basic computer operations
• Strong verbal and written communication skills

Roles and Responsibilities

Team Leadership & Oversight:

• Lead and supervise the Regulatory Affairs team, including indirect supervision of a Technical Clerk and direct oversight of the Company Pharmacist.
• Monitor team performance and ensure timely completion of deliverables aligned with regulatory and departmental objectives.
• Implement strategic regulatory directions set by the R&D/Regulatory Division Manager.

Regulatory Compliance & Documentation:

• Prepare, review, and ensure accuracy and completeness of technical dossiers for local and export product registrations.
• Coordinate closely with internal departments (Technical Services, Quality Control, Formulation, Marketing) on all aspects of product registration.
• Submit complete and compliant dossiers to strengthen local and international regulatory adherence.
• Maintain active and updated records of registration requirements across Asia and the Pacific.

Regulatory Submission & Coordination:

• Facilitate and secure approvals of product registration applications from relevant regulatory agencies.
• Coordinate with clients regulatory counterparts for dossier preparation and submission requirements.
• Provide regulatory guidance and support to Accounts Management, Technical Services, and R&D on FDA regulations.
• Serve as the Pharmacovigilance Officer, ensuring compliance with post-marketing safety reporting requirements.

Operational Responsibilities:

• Ensure efficient registration and renewal of local and export products, licenses, cGMP certificates, and permits.
• Protect confidential documents, product formulations, and other sensitive information encountered in the role.
• Maintain proper use and care of assigned equipment, particularly computer systems.

External Relations:

• Interface with clients and both local and international regulatory agencies regarding product registration matters.

Knowledge:

• Basic GMP principles
• Basic understanding of ISO 9001:2015 and EHS (Environmental, Health & Safety)
• Problem solving, decision-making, and root cause analysis
• Project and performance management
• Targeted selection and customer service excellence
• Licensing requirements for drug establishments
• Regulatory guidelines for product registration
• Quality Management System (QMS) concepts and principles