Regulatory Affairs Officer
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Key skills for this role
About the Role
Complete registration formalities, review documentation, maintain regulatory authority contact, and provide logistic support for timely product approvals.
Key Skills for This Role
Responsibilities
- Complete registration formalities for pharmaceutical, veterinary, and medical products
- Review regulatory documentation and technical product information
- Provide regulatory support for portfolio of products
- Establish and update registration database
- Update licenses and collect information on registration instructions and regulations
- Complete forms and requests from government agencies (DM)
- Carry out follow up and pricing negotiations to obtain approval
- Check all import permits
- Maintain contact with regulatory authorities
- Communicate with regulatory bodies in DM & MOH to facilitate product launch
- Provide logistic teams with regulatory input for timely approvals
- Perform pharmacovigilance activities including SOP preparation and staff training
Requirements
- 1 7 years of experience in regulatory affairs
- Knowledge of pharmaceutical, veterinary, and medical product registration
- Ability to review regulatory documentation and technical product information
- Experience with government agencies (DM, MOH)
Full Job Posting
Key Responsibilities
- Complete registration formalities for Pharmaceutical, Veterinary and Medical products
- Review regulatory documentation and technical product information
- Provide regulatory support for portfolio of products
- Establish and update registration database in the company
- Update licenses and collect information on registration instructions and regulations
- Provide and complete forms needed in registration
- Complete forms and requests originating from government agencies (DM)
- Carry out all subsequent follow up and pricing negotiations necessary to obtain the approval
- Checking all import permits
- Maintain contact with regulatory authorities
- Communicate with regulatory bodies in DM & MOH to facilitate successful product launch
- Establish healthy & effective relationship with all concerned personnel at DM
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