Regulatory Affairs Associate
Brady Pharma Inc. Mandaluyong Full-time
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
- Must be a Licensed Pharmacist
- With experience working in Regulatory
- Fresh graduates 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
Work Location: In person
Square Pharmaceutical, IncCarmona, 30 km from Mandaluyong
About the role
We are seeking a highly motivated Regulatory Affairs Officer to join our dynamic team at Square Pharmaceutical, Inc' in Carmona Cavite. As a Regulatory Affairs Officer, you will play a crucial role in ensuring our pharmaceutical...
Brady Pharma Inc.Mandaluyong
Qualifications:
• Female
• Must be a Licensed Pharmacist
• With at least two (2) years or more working experience in Regulatory
• Must be familiar and knowledgeable in the registration of Drugs, Cosmetics, Medical devices, and Food products...
Information ProfessionalsTaguig, 8 km from Mandaluyong
WFH but must be willing to work onsite if needed.
• Must have advance excel skills (Pivot and Vlookup)
To manage compliance documentation, preparing regulatory filings (applications, reports, renewals), and acting as a liaison between...