Documentation & Regulatory Officer
2 weeks ago
Job Summary:
The Documentation & Regulatory Officer is responsible for assisting in the management of regulatory documentation and ensuring that all regulatory requirements are met in accordance with applicable laws and standards. The officer is responsible for preparing, organizing, and maintaining regulatory submissions and records to ensure the company's compliance with local and international regulations in the manufacturing and distribution of veterinary products.
Duties and Responsibilities:
- Assist in preparing and submitting regulatory documents, ensuring all necessary paperwork and approvals are obtained in a timely manner.
- Maintain accurate records of regulatory submissions, correspondence, and approval statuses for all products.
- Review regulatory documents for completeness, accuracy, and compliance with regulations before submission to regulatory agencies.
- Support the regulatory affairs team by researching and interpreting regulatory requirements for various markets.
- Help ensure that all product labels, packaging, and marketing materials are compliant with regulatory standards.
- Participate in internal audits of regulatory processes and ensure that corrective actions are implemented as needed.
- Monitor regulatory changes and assist in implementing processes to stay compliant with new or updated regulations.
- Assist in organizing regulatory files, ensuring that documents are properly indexed and archived for future reference.
- Liaise with cross-functional teams, including production and quality assurance, to facilitate regulatory compliance in product development and manufacturing.
- Assist with the preparation and submission of product registration dossiers, ensuring that all required documents are complete and up-to-date.
- Assist in preparing regulatory reports for senior management, outlining key developments and potential regulatory risks.
- Contribute to achieving departmental objectives by performing additional duties as assigned by the Documentation & Regulatory Manager or Head of Regulatory Affairs.
Qualifications:
a. Educational Level: Bachelor's degree in Pharmacy, Life Sciences, or a related field
b. Degree / Course: Pharmaceutical Sciences, Regulatory Affairs, or related fields
c. Behavioral Competencies: Detail-oriented, organized, effective communication, proactive, collaborative
d. Technical Skills: Knowledge of regulatory affairs, document management systems, and regulatory submission processes
e. Years of Related Experience: At least 2-4 years of experience in regulatory affairs, documentation, or quality assurance in a pharmaceutical or manufacturing setting
Willing to be assigned at SAN MATEO RIZAL
Job Types: Full-time, Permanent
Pay: From Php25,000.00 per month
Benefits:
- Additional leave
- Company Christmas gift
- Company events
- Free parking
- Health insurance
- Life insurance
- On-site parking
- Opportunities for promotion
- Promotion to permanent employee
Work Location: In person
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