Regulatory Affairs Pharmacist
2 weeks ago
Job Summary:
The Regulatory Affairs Pharmacist is responsible for managing and ensuring the compliance of pharmaceutical products with all applicable regulatory requirements. This position involves preparing, submitting, and maintaining necessary documentation for the registration and approval of veterinary medicines, vaccines, and related products. The Regulatory Pharmacist will collaborate with internal teams and regulatory authorities to ensure all products meet safety, efficacy, and quality standards.
Duties and Responsibilities:
- Ensure compliance with local and international regulatory requirements for veterinary medicines and vaccines by preparing and submitting registration dossiers for approval by regulatory authorities.
- Review and interpret regulatory guidelines and advise the company on the necessary steps to meet compliance standards for new and existing products.
- Monitor and stay updated on regulatory changes and industry trends that affect the approval and commercialization of veterinary products.
- Coordinate with the production, R&D, and QA/QC teams to ensure that all regulatory documentation aligns with product specifications and regulatory requirements.
- Prepare and submit required documentation for regulatory approvals, including product labeling, clinical trial data, stability data, and manufacturing processes.
- Liaise with regulatory authorities during product registration processes to clarify queries and expedite approvals.
- Review and approve marketing materials and product labeling to ensure compliance with regulations and prevent misrepresentation of product claims.
- Maintain accurate and up-to-date records of regulatory submissions, approvals, and regulatory correspondence.
- Assist in the preparation and management of periodic regulatory reports, including renewal submissions and post-market surveillance requirements.
- Review changes to manufacturing processes, formulations, or packaging to determine if new regulatory submissions or approvals are required.
- Coordinate the product registration renewal process to ensure continuous product availability in the market.
- Provide regulatory support to cross-functional teams (e.g., Sales, Marketing, Production) by answering regulatory-related queries and ensuring compliance across all company functions.
- Participate in internal and external audits, inspections, and reviews to ensure continued regulatory compliance.
- Support the preparation of responses to regulatory authority inquiries and issues, ensuring timely and comprehensive submission of required information.
- Contribute to achieving departmental objectives by performing additional duties as assigned by the Regulatory Affairs Manager or Head of Regulatory Affairs.
Qualifications:
a. Educational Level: Bachelor's degree in Pharmacy or related field
b. Degree / Course: Pharmacy degree, or equivalent in a related scientific discipline
c. Behavioral Competencies: Strong attention to detail, critical thinking, excellent communication skills, ability to collaborate with cross-functional teams, proactive approach to problem-solving
d. Technical Skills: Knowledge of regulatory affairs and the registration process for veterinary medicines and vaccines, familiarity with local and international regulatory standards (e.g., FDA, EMA), proficiency in MS Office and regulatory management software
e. Years of Related Experience: 3-5 years of experience in regulatory affairs, preferably in pharmaceuticals, veterinary products, or biologics
WILLING TO BE ASSIGNED AT SAN MATEO RIZAL
Job Types: Full-time, Permanent
Pay: Php25, Php28,000.00 per month
Benefits:
- Additional leave
- Company Christmas gift
- Company events
- Free parking
- Health insurance
- On-site parking
- Opportunities for promotion
- Promotion to permanent employee
Work Location: In person
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