Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.
Post : Assoc Dir Regulatory Affairs
Job Description
• Ensure adequate and quality Deficiency Responses are submitted in time.
• Thorough review of documents to maintain submission quality
• Review and compile ANDA documents.
• Ensure quality of ANDAs, so as no RTRs are received
• Preparing and maintaining Deficiency tracker
• Skills and specific knowledge required
• Expertise in preparation of dossiers and electronic submission for Health Authorities for North America markets
• Must have experience Aware of various health authority guidelines like ICH, USFDA, HC
• Good communication and co-ordination skills
• Good drafting skills to prepare quality responses
• Acknowledge and understand the deficiency letters received from USFDA and HC.
• Promptly communicate and share the Deficiency letters and prepare a response strategy.
• Work with the various stake holders and co-ordinate to get right documents and ensure timely submissions of responses.
• Drafting of responses for Deficiency letters or Clarifaxes
• Lead a team and provide support to prepare high quality submissions
• Escalate issues which can delay submissions, can cause RTRs or result in suboptimal submissions
• Review of Compiled dossiers
• To maintain and update regulatory database
• Perform all other regulatory activities as required by management.
Candidate Profile
• B.Pharm / M.Pharm / M.Sc / Ph.D
• About 10- 15 years experience in the profession of Regulatory Affairs
• Experience of filing atleast 10 ANDAs
Additional Information
Qualification : B.Pharm / M.Pharm / M.Sc / Ph.D
Experience : 5+ yrs
Location : Navi Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th December, 2019
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