We are seeking a Regulatory Pharmacist to join our company, an organization in the pharmaceuticals and medical devices sector. This is a full-time position based in Paranaque City, Metro Manila. As a Regulatory Pharmacist, you will play a critical role in ensuring that our pharmaceutical and medical device products comply with all applicable regulatory requirements and standards. This position is strategically important to our organization, as it ensures our products meet the highest safety, efficacy and quality standards whilst navigating complex regulatory landscapes. You will be instrumental in supporting our company's growth and market expansion by facilitating timely regulatory approvals and maintaining compliance across all our operations.

Responsibilities

1. Prepare, review and submit regulatory documentation and applications to relevant pharmaceutical and medical device regulatory authorities
2. Ensure all pharmaceutical products and medical devices comply with current regulatory requirements, including Good Manufacturing Practice (GMP) and Good Warehousing Practice (GWP) standards and quality guidelines
3. Monitor and interpret changes in pharmaceutical and medical device regulations, ensuring the organisation remains compliant with all legislative requirements
4. Provide expert regulatory advice to cross-functional teams including Research and Development, Quality Assurance and Commercial teams
5. Conduct regulatory risk assessments for new products and formulations prior to market entry
6. Maintain and update regulatory documentation, including technical files, quality overall summaries and product information
7. Liaise with regulatory bodies and respond to regulatory enquiries and requests for information
8. Support the development and implementation of standard operating procedures (SOPs) related to regulatory affairs
9. Conduct internal audits and compliance checks to ensure adherence to regulatory standards
10. Stay current with international regulatory guidelines and industry best practices in pharmaceuticals and medical devices

Job Requirements

1. Bachelor's degree in Pharmacy or equivalent pharmaceutical qualification with appropriate regulatory knowledge
2. Minimum of 3-5 years' professional experience in a regulatory affairs or quality assurance role within the pharmaceuticals or medical devices industry
3. Strong knowledge of pharmaceutical and medical device regulations, including local Philippine regulations and international standards
4. Excellent understanding of GMP and GWP, quality management systems and regulatory compliance requirements
5. Proven experience in preparing and submitting regulatory documentation and applications
6. Strong analytical and problem-solving skills with the ability to interpret complex regulatory requirements
7. Exceptional communication skills, both written and verbal, with the ability to explain technical regulatory matters clearly
8. Proficiency in Microsoft Office applications and regulatory information management systems
9. Attention to detail and commitment to maintaining accuracy in all regulatory documentation
10. Professional registration or certification as a pharmacist recognised in the Philippines
11. Experience with pharmacovigilance, post-market surveillance or product lifecycle management is highly desirable