Job for Manager Regulatory Affairs in Fast Growing Pharma Co. - Aspiring-Solutions
Our client, established in the year 1986, is the world’s second largest Integrated manufacturer of Ephedrine and Pseudo ephedrine salts. Our client's manufacturing facility at Mahad has been audited and approved by the Australian TGA, and the US FDA
Post : Manager Regulatory Affairs
- Experience in compilation, review and submission of CTD dossiers to foreign drug agencies in ROW markets as well as general laisoning with the local FDA.
- Interacting with the R&D centre as well as respective manufacturing sites.
- Overall responsibility for timely submission of dossiers to the company’s foreign branches as well as replies to the concerned foreign agencies.
- Responsible for the company to maintain its local GMP and product licenses from the Maharashtra FDA and the CDSCO.
- Write high quality deficiency response to various regulatory authorities.
- Knowledge of commercial regulatory requirements for all the regulated markets.
- Should have knowledge of registration process , plant audits.
- Compilation & review of dossier including technical data package.
- Review of Batch records, specification, art work, and packaging material, analytical method validation documents, development documents, PDR and labelling.
- Must also have knowledge of about ROW market and other market from dossier preparation and query solving point of view.
· B.Pharm and/or M.Pharm graduate.
· Have 10-15 experience in regulatory and/or quality assurance.
· well versed with the FDA & CDSCO online portal
· well versed with the drugs & cosmetics act, in particular Schedule M & WHO guidelines.
· Male Candidates preferred
Job Location: Chandivali, Mumbai
Education: B.Pharm/ M.Pharm
Experience: 10-15 years experience into Pharma Regulatory
Industry: Pharma/ Biotech
Function Area: Regulatory Affairs
Key Skills: ROW, CTD, ACTD, pharma regulatory affairs, RA, manager, formulation
Salary Range: 10-12 Lacs per annum
Mail your cv at email@example.com with details on current ctc, expected ctc and notice period.
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