Career at Themis Medicare as a Head Regulatory Affairs

Themis Medicare is headquartered in Mumbai with four state-of-the-art manufacturing facilities at three locations, in Vapi (Gujarat), Hyderabad (Andhra Pradesh), and Haridwar (Uttaranchal).
Even though, Active Pharmaceutical Ingredients account for a significant portion of Themis Medicare's revenue, the Company is setting new benchmarks in manufacturing and marketing formulations. The company has prudently addressed relevant and growing therapeutic areas like antituberculosis, antimalarials, cardiology, pain management, anti-infectives, haematinics, Health & Nutrition. The company is also engaged in co-marketing its research based formulations with other pharmaceutical companies in India and abroad.

Post: Head Regulatory Affairs

Job Description:
a. Candidate must have worked in Regulated, Semi Regulated and ROW Markets.
b. Proven experience of Preparing Dossiers in CTD and eCTD. Responsible for submission of technical tender documents for international and domestic tenders
c. Should have filed API and intermediates DMF independently.
d. Should have experience in QC, Experience of Analytical Method Development.
e. Responsible for adhering to ICH and CGMP guidelines and ensure the implementation of the same.
f. To co-ordinate with different support functions like Q.A and Q.C for effective & time bound operations.
g. Capable of identifying project or team issues in advance and seeking necessary help and support to resolve.
h. Should have successfully faced various regulatory audits like WHO, MHRA, EDQM, Internal Auditors, able to face queries of suppliers etc. Handling and sorting out technical queries received from agents and health authorities of respective countries for registration of products.

Additional Information:
Experience: 10-20 Years
Location: Mumbai
Education: B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 21^st August, 2011