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
- 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
Please email your cv at firstname.lastname@example.org with details on current CTC, expected CTC and notice period