
Regulatory Affairs Associate
7 days ago
Duties & Responsibilities
- Assist in preparing all the technical documents required for submission to FDA and other regulatory agencies
- Responsible for ensuring that all product registrations, licenses, and certificates are valid and submitted to the FDA for renewal prior to the expiration date
- Update and monitor the registration status and validity date of all regulatory certificates and licenses
- Establish and maintain document filing system to ensure easy access
- Participate in inspections of company facilities by FDA and other applicable agencies
- Submission of Quarterly report for DOH EDPMS
- Act as a Person in charge, liaison to local regulatory bodies
- Assist in the preparation of Bidding Documents for submission on Public Bidding for Hospitals
- Assist in preparing Requirements for Hospital needs.
- Assist in Sales concerns about product specification and other concerns.
- Assist the Marketing Department with Promo Permits for FDA compliance
- Handles Batch Notification for FDA Monitoring
- Provides support and assistance to Regulatory Affairs Head
- Perform other regulatory-assigned activities and roles in support of business objectives
Qualifications
- Must be a Licensed Pharmacist
- With or Without experience working in Regulatory
- Fresh Graduaes are welcome to apply
- Background in handling government account procedures is an advantage
- Excellent leadership and management skills
- Honest, patient, and hardworking
- Willing to work onsite from Monday to Friday
Job Type: Full-time
Work Location: In person
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