Designation : Manager / Sr. Manager - Regulatory Affairs
Role : Manager / Sr. Manager
Functional Area : Regulatory Affairs
Education : B.Pharm / M.Pharm / M.Sc.(Micro Chemistry)/Ph.D.
Industry Type : Pharma, Biotechnology
Experience : 12 - 20 Years
Compensation : Negotiable
Location : Dholka
- Well versed with compilation, review, amend and submission of Drug Master files to various regulatory authorities i.e. US, EUROPE, Canada & other countries.
- Review and update CEP dossier for the submission to EDQM.
- Review queries of FDA, EDQM, regulated and emerging markets.
- Review and make necessary corrections in validation documents such as process validation, AMV of assay, related substance, residual solvents etc.
- Review and update TDP, STP of raw materials, finished products and packing material to support regulatory queries.
- Review the changes affected to the regulatory submission and to check the impact on the regulatory filling through change control document.
- Submit DMF in eCTD, Query response and other regulatory documents through various platforms such as ESG, CESP, EMA gateway etc.
- Review and submission of Life Cycle management of DMFs (Variations/Amendments/Annual updation as per schedule).
- To lead and provide guidance and trouble shooting of technical activities related to Quality control and quality assurance..
- Responsible for responding to the FDA and liaison with US and European regulatory authorities.