SAVA Global Needs Head Regulatory Affairs

SAVA Medica Limited is a leading pharmaceutical company based in India.
Human life is precious to us. That is why we, at SAVA Medica, are committed to provide such products which can improve human health & life at affordable cost.
To accomplish our aim we, at SAVA Medica, are engaged in manufacturing & marketing of the branded generic medicines at affordable prices.

Post: Head Regulatory Affairs

Job Description:
1) Providing regulatory pathways for the submission of a generic product dossier in US and Europe for ophthalmic specialty products. Review and submission of ANDA/ product dossiers for Global Regulatory Agencies like USFDA, Health Canada, TGAm EMEA, MHRA
2) Shall be responsible Regulatory Affairs function for developed / regulated & Non-Regulated market particularly for US & Europe & ROW & lead a group of regulatory professionals.
3) Organizing the required documents for CTD for Regulatory submission.
4) Respond to queries raised by regulatory authorities.
5) Implementation of eCTD and SPL.

6) Preparation of drug master files, site master files and dossiers for Regulated & ROW countries.
7) Review of specifications like RM, FP and Stability for regulatory compliance.
8) Coordination with various departments like R&D, AD, QC, QA, Production, Validation and International Marketing.
9) Response to queries of various agencies of various countries.
10) Pre & post approval compliance as per various regulatory authorities’
11) 15 to 20 yrs. experience in Regulatory Affairs (Regulated & Non-Regulated market)

Additional Information:
Experience: 15-20 Years
Location: Pune
Education: B.Pharm, M.Pharm, B.Sc, M.Sc, MBA
Indusrty Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 23^rd Oct., 2011