Regulatory Affairs Officer for FDA Certificate of Product Registration
1 week ago
Job Summary:
Regulatory affairs officers act as a link between companies and regulatory authorities, ensuring that products are distributed in compliance with appropriate legislation.
Duties and Responsibilities:
- Ensure that company's products comply with the regulations of the regions where they should be distributed (BFAD, FDA, BAI, NMIS, BIR, etc.)
- Ensure that quality standards are met and submissions meet strict deadlines.
- Keep up to date with national and international legislation, guidelines and customer practices.
- Prepare submissions of license variations and renewals to strict deadlines.
- Review company practices and provide advice on changes to systems
- Liaise with regulatory authorities.
Qualifications:
- At least 1-2 years experience in related field.
- Must Have experience in filing the FDA Certificate of Product Registration (CPR)
- Knowledgeable with local distributor compliance process
- Excellent written and verbal communications skills
- Good coordination skills and keen attention to details
Job Type: Full-time
Pay: Php25, Php35,000.00 per month
Benefits:
- Health insurance
- Life insurance
- Promotion to permanent employee
Ability to commute/relocate:
- Makati: Reliably commute or planning to relocate before starting work (Preferred)
Application Question(s):
- Do you have experience in Filing the CPR / Certificate of Product Registration to FDA?
Experience:
- FDA CPR : 2 years (Preferred)
Work Location: In person
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