Opportunity for Regulatory Affairs Manager in Aspiring-Solutions

Our client is one of the players in the pharma industry striving to be amongst the top fine pharma companies.

Post: Regulatory Affairs Manager (ROW Markets)

Job Description:
* 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.

Candidate Profile
· 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

Additional Information:
Education: B.Pharma, M.Pharm
Experience: 10-15 yrs
Location: Chandivali, Mumbai
Industry: Pharma/Biotech
Last Date: 20^th May, 2017

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