Manager Regulatory Affairs - Delhi

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

• Registration of NCE and line extensions for therapeutic area of responsibility


• Strategies compliant 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 regularly and engage in impactful discussion with Senior Regulatory officials.


• 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.


• Regulatory Intelligence, 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 8-10 years.


• Proven track record of Strong Liaising experience in the health authority


• 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

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

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