Teva Regulatory Affairs Associate 

India, Goa 

857888103

• Compile module 3 and corresponding module 2.3 Quality Overall Summary (QoS) for presentation to regulatory authorities or clients
• Critically evaluate the content of module 2.3 and module 3 in terms of completeness and relevance for supporting a new registration.
• Evaluate change controls with respect to its impact on regulatory submissions, strategize filing category in accordance with the relevant guidelines and compile variation packages
• Respond to queries (from regulatory authorities or clients) concerning dossiers. Manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company (e.g. suppliers)
• Keep departmental database or other tracking systems up to date.
• Act as main liaison and work closely with all departments at site and across business units
• Abide by ICH guidelines and other relevant regulatory provisions, GMP requirements, occupational and environmental safety guidelines and internal SOPs
• Keep up to date with regulatory requirements and other developments in the pharmaceutical industry, including relevant legislations and guidelines (EU, US and RoW) and pharmacopoeias
• Any other duties as required/assigned by the company and/or direct superior.

• B.Pharm/M.Pharm
• 2-4 Yrs in handling related/ equivalent tasks- Regulatory Affairs experience with Europe & International market

• Very good command of English, speaking and writing
• Good IT skills
• Working under general supervision
• Ability to work in a team.
• Communication skills with internal and external customers.
• Organisation skills.
• Result-oriented.
• Responsible and Pro-active.
• Accuracy in practice and attention to detail.

Associate Director, Regulatory Affairs