At Amgen, we believe in a “biology first” approach. We use cutting-edge science and technology to study the subtlest biological mechanisms in search of therapies that will improve the lives of those who suffer from serious diseases. Amgen believes the cure for disease can be found inside each and every one of us.
Job Title: MANAGER- REGULATORY AFFAIRS
No. of Posts: 1
This role will ensure timely and robust functional/cross-functional coordination, transparent execution and implementation of Regulatory Affairs processes and deliverables in order to support Amgen partners involved in commercialization and maintain local clinical trial authorizations.
- Coordinate and review all marketing and import registration applications complied by the business partner to ensure filing timelines and approvals from CDSCO are adhered to.
- Collaborate with Amgen internal stakeholders such as regional regulatory affairs, CMC, Labelling, Supply Chain, Quality, Medical Affairs and Safety to support seamless execution of commercial filing and launch plans.
- Compile and adapt clinical trial applications per local regulations, ensuring timely submissions, follow-up with and approval from the regulatory authorities
- Respond to regulatory queries seeking support and feedback from appropriate functions within Amgen
- Ensure regulatory compliance by managing regulatory submissions for notification and/ or approval during the course of the execution of each clinical study including preparation and submission of annual study status reports and study completion reports
- Ensure timely registration and maintenance of all approved clinical trials in the Indian clinical trials registry (CTRI)
- Import & export license submission, approval and maintenance for clinical trials.
- Troubleshoot with line management any critical path activities which impact submission with line management.
- Keep up to date on the implementation of key legislation, regulatory policy and guidance ensuring changes or updates are communicated.
- Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products and understand the impact on current and future submissions
- Ensuring that local labeling requirements are developed in alignment with local regulatory requirements and Amgen standards
- Ensure maintenance of country-specific details captured in regulatory knowledge center on Amgen GRAAS databases & communicate changes regulatory requirements and their impact to Amgen to key customers and stakeholders
- Participate in process improvement initiatives, and recommend process changes where necessary
• Education: Bachelor’s degree or Master degree in Life Sciences or equivalent or B Pharm or M Pharm
• Typically 4+ years of related professional experience in the pharmaceutical / biotechnology pharmaceutical or medical device industry for India registration
• Experience in Regulatory Affairs.
• CMC specific regulatory knowledge and experience; Clinical Application and market applications (MAAs or variations).
• Strong oral and written communication skills.
• Fluent in English
• Experience in domestic regulations (India registration) is must.
• Experience in international working environment preferred.