Manager Regulatory Affairs for a Fast Growing Pharma Co., Mumbai

We are urgently hiring for Manager Regulatory Affairs for a fast growing  Pharma co. for their HQ located at Andheri East, Mumbai . Please find the details below:


Company Name:
 Fast Growing Pharma Co.
Requirement: 1 Nos.
Job Location: Andheri East, Mumbai
Designation: Manager Regulatory Affairs
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

Job Profile: 

  • 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.

 

Requirements:

  • 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

Please email your cv at aspsol.recruitments@gmail.com with details on current CTC, expected CTC and notice period

 

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