Regulatory Affairs Associate
3 days ago
Job Title : Regulatory Affairs Associate
Reports to: Regulatory Affairs Manager
Ajanta Pharma Philippines,Inc.
Regulatory Affairs Associate
Job Description
Responsibilities
- Prepare submission of new product licenses and license renewals with the overview of the Regulatory Affairs Manager
- Prepare submissions of license variations and renewals based on expiration of CPRs and compliance to strict deadlines
- Monitor and set timelines for drug license variations and renewal approvals
- Write clear, accessible product labels, patient information leaflets and product inserts
- Monitoring of commercial batches align with FDA labeling requirements
- Ensure that a company's products comply with the regulations of Philippines Law including the FDA Philippines regulations
- Collate, evaluate and check scientific data from a range of sources including post marketing surveillance (phase 4)
- Prepare and check regulatory documentations as needed in public tender and other sales and marketing-related concerns
- Take part in the development of marketing concepts and approve packaging and advertising before a product's release in conjunction with product management
- Maintain proper archive of regulatory documents for reference and easy retrieval
- Perform other duties that may be assigned by superiors
Qualifications and Skills
- Graduate of Pharmacy or Industrial Pharmacy
- Updated Valid PRC Pharmacy License
- With at least 1-to-2-year experience in regulatory affairs with Phil. FDA particularly handles drug products
- Understanding of both legal and scientific matters pertaining to pharmaceuticals
- The ability to grasp new concepts quickly and to assimilate and evaluate scientific data from scientific literature
- Analytical and problem-solving skills
- Written and oral communication skills
- Attention to detail
- The ability to work under pressure and to strict deadlines
- The confidence to report to higher management
- Team working skills
- Project-management skills
- Integrity and a professional approach to work
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