Work as a Manager Regulatory Affairs @ Themis Medicare
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: Manager Regulatory Affairs
• Proven experience of Preparing Dossiers in CTD and eCTD
• Responsible for submission of technical tender documents for international and domestic tenders.
• Handling and sorting out technical queries received from agents and health authorities of respective countries for registration of products.
• Responsible for adhering to ICH and CGMP guidelines and ensure the implementation of the dame.
• To co-ordinate with different support functions like Q.A and Q.C for effective & time bound operations.
• Capable of identifying project or team issues in advance and seeking necessary help and support to resolve.
• Ability to derive creative solutions to Regulatory problems, whilst balancing the expectations of the management team and ensuring compliance with regulation in all regions.
• Co-ordination with quality assurance, quality control, R&D, packing, production for technical data.
• Should have successfully faced various regulatory audits like WHO, MHRA etc.
• Should have experience in both API & Formulation division.
B.Pharm/M.Pharm with 5 - 8 years experience in similar capacity.
Should have good written and oral communication skills.
Should have interpersonal skills, a great influencer and one who is possessing a self starting attitude.
Should be aggressive in work.
Experience: 5-8 Years
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
End Date: 18th July, 2011
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