Regulatory Affairs Associate
Full-time
BAUCH (Phils.) Laboratories Corp.
BAUCH (Phils.) Laboratories Corp. is seeking a highly organized and proactive Regulatory Affairs Associate to support both pharmaceutical & nutraceutical product registrations and environmental, health, and safety compliance activities.
This role supports the company in QA Compliance, product registrations, permits, and compliance documentation are properly maintained and submitted to the appropriate authorities while supporting the company’s commitment to standards, regulatory excellence, workplace safety, and environmental responsibility.
Key Responsibilities:
Pharmaceutical / Food Supplement Registration and Renewal
- Process LTO and cGMP renewals of the manufacturing plant, assist toll manufacturing clients on regulatory advice (CPR Application/Renewal) to Food and Drug Administration (Philippines), and other regulatory compliance bodies.
- Manage applications, variations, and renewals of pharmaceutical and nutraceutical product licenses.
- Maintain regulatory documentation and monitor submission timelines.
- Ensure product labels, packaging materials, and product information comply with regulatory requirements
- Coordinate with Quality Assurance, Quality Control, Production, and Research & Development teams for documentation needed in product registrations and updates
Environmental, Health & Safety (EHS) Compliance
- Coordinate with the PCO and Safety Officer for the environmental and occupational safety compliance documentation with agencies such as Department of Environment and Natural Resources, Laguna Lake Development Authority, Department of Labor and Employment, Bureau of Fire Protection, Philippine Drug Enforcement Agency, and other relevant authorities
- Maintain records of environmental permits, safety documentation, and compliance reports
- Work closely with the designated Pollution Control & Safety Officer to ensure timely submission of required reports and permits
- Support workplace safety and environmental programs in coordination with internal teams
- Assist during inspections, audits, and government visits
Qualifications
- Graduate of Pharmacy (License is not required, but a plus), or other related health sciences.
- Experience in pharmaceutical regulatory affairs or product registration is preferred
- Training or familiarity with Pollution Control Officer (PCO) and Basic Occupational Safety and Health (BOSH) programs is an advantage, but not required.
- Strong documentation, organization, and compliance monitoring skills
- Excellent coordination and communication abilities
- Detail-oriented, proactive, and able to manage multiple regulatory timelines
- Willing to work on-site in Silang, Cavite, 48 hours per week.
Why Join Us?
- Contribute to both pharmaceutical regulatory excellence and operational compliance
- Gain exposure to product lifecycle management, environmental compliance, and safety systems
- Be part of a growing pharmaceutical manufacturing team committed to high standards and continuous improvement
About Bauch:
BAUCH (Phils.) Laboratories Corp. is an innovative toll pharmaceutical and manufacturing laboratory situated in Silang, Cavite. We are dedicated to achieving excellence through modern methods and high-technology systems, ensuring compliance with Philippine FDA cGMP/PICS standards.
Vacancy posted more than 2 months ago
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