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

Job Description

• 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.