Manager Regulatory Affairs For A Fast Growing Pharma Co Mumbai Job In Aspiring Solutions In Mumbai

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

Company Name: Fast Growing Pharma Co

Requirement: 1 Nos

Job Location: Chandivali, Mumbai

Designation: Manager Regulatory Affairs

Education: B.

Pharm/ MPharm

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

Key Skills

regulatory affairs manager, ROW, pharma, mumbai, RA, QA, quality assurance, dossier filing

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

Aspiring Solutions is looking for MBA / PGDM / MBM , B.Pharma , Diploma , M.Pharma profile candidates.

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

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