Manager Regulatory Affairs - Delhi

Job description

**The Position** Ensure that all regulatory updates are shared with local and global teams in timely manner. Ensure that timely and complete regulatory actions are taken regarding assigned product/therapeutic area. Ensure operational RA tasks are executed in timely manner **Tasks & Responsibilities** - Strategies comply with regulations, Liaise with Health Authority and ensure earliest submission and registration in the country. - Follow-up regulatory approvals for the products per registration plan. - Liaise with Health Authority and Ensure earliest submission & approvals at the right time to ensure quick implementation of proposed CMC changes as per global timelines. - Renewal on time to ensure uninterrupted availability of products in the country. - Amendments and updates are approved on time to ensure study is continued in the country and ensure timely notification of notifiable updates. - Follow-up on submitted applications at HA. - Ensure all regulatory updates are shared with local and global team in timely manner. - Follow the RI procedure of making entry and impact assessment of each relevant update in RINTOOL to maintain RIN database. **Requirements** - Education: Bachelor’s degree in pharmacy or similar medical education. - Pharma experience with regulatory focus in a multi-national for at least 4-6 years. - Solid understanding of D&C Act and Rules. - Understanding of working practices at HA. - Experience of direct interactions with Regulatory Authorities. - Eye for details - Analytical skills - Communication skills - Negotiation skills - Position is based in Delhi **READY TO APPLY?** Click the “Apply On Company website” button. Create an account or sign in and continue to register your profile, upload your resume, and apply in the company site. Our Company **Why Boehringer Ingelheim?** With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better. Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations. Want to learn more? Visit https://www.boehringer-ingelheim.com