Require Regulatory Affairs Manager at Teva Pharmaceutical

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.

Post : Mgr Regulatory Affairs

Job Description
• RA professional with in depth technical knowledge of CMC aspects, dossier compilation, review, evaluation and compilation of post approval changes.
• Hands on experience to review and approve submission documents in accordance with the regulatory guidelines, evaluate changes in CMC documentation with respect to its impact on regulatory submissions, strategize filing categories, compile submissions to Europe, International market
• Coordinate with internal and external stakeholders and compile high quality regulatory submissions,within stipulated timelines and accordance to the guidelines, ensuring submission documents are accurate, compliant, and high-quality.
• To assess regulatory documents in consideration and compliance with the regulatory requirements at a preliminary level & provide inputs to cross functional team to support business requirements
• Independently evaluate change controls with respect to its impact on regulatory submissions, strategize filing category, compile submissions and resolve complex issues as they raise for EU, international markets.
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
• Result-oriented with concerns for quality and the ability to handle multiple tasks and work in a cross-functional team environment and project teams/ buisness units

Candidate Profile
M.Pharm/B.Pharm with 10- 13yrs of experience in Regulatory Affairs

Additional Information
Qualification : M.Pharm/B.Pharm
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th November, 2019