Regulatory Affairs Officer

Job Description

Assists the Senior Regulatory Officer in product registrations and securing operational licenses with various Regulatory Agencies (FDA, DENR, BAI) for the assigned Business Units or Product Categories.

Use pharmacist license for LTO and registration of Cosmetics and Personal Care products.

Assists Marketing in finalizing product labels, and product claims, and securing supporting documents in accordance with FDA guidelines.

Major Responsibilities

1. To prepare the registration dossier of new products and Certificate of Product Registration (CPR) renewals, file dossiers with FDA, and ensure that certificates are released and updated.
2. To ensure that the company’s Licenses to Operate for all Business Units are renewed and updated on time.
3. To take charge during inspection visits of FDA representatives. Ensure that all documents are ready, office and warehouse are in order.
4. To inform Management of any new guidelines, or rulings being issued by FDA about product registrations and licenses affecting our product categories
5. To represent the company in FDA forums; attend seminars and workshops required by FDA.
6. To establish a Tracking Monitoring System for all licenses and Certificates of Product Registration (CPR) for all CCPI products.

Contacts Arising Out of the Job

1. Internal

• Marketing
• Research and Development
• Sales
• Accounting
  

1. External

• Food and Drug Administration, Bureau of Animal Industry Toll Manufacturers (API) Pharmacists Association

Qualifications

1. A licensed Pharmacist
2. Good in planning and organizing
3. Preferably has experience in dealing with FDA
4. Assertive, resourceful and has initiative
5. With good oral and written communication skills
6. Pleasant personality