Manager Regulatory Affairs
Job ID: R-35277
India – Mumbai
Posted Date: March 15, 2017
This is an opportunity within the Global Regulatory Affairs and Safety (GRAAS) Department located in Amgen Pvt. Ltd, in Mumbai, India. .
The Manager of Regulatory Affairs will report to the Head of Regulatory Affairs located in Mumbai, India. This role is focused on supporting the execution of Amgen’s commercial plans in India by effectively coordinating with the commercial partner to ensure all aspects with respect to commercial applications and approvals are in compliance to Amgen corporate and local regulatory requirements. The role also involves managing all aspects of the clinical trial application and approval process including maintenance activities for ongoing clinical trials.
This role will ensure timely and robust functional/cross-functional coordination, transparent execution and implementation of Regulatory Affairs and safety processes and deliverables in order to support Amgen partners involved in commercialization and maintain local clinical trial authorizations. To act as a contact with DCGI’s office and assist in the management of the local regulatory function. This role may include supervisory responsibilities.
Key responsibilities include:
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 Commercial to support seamless execution of commercial filing and launch plans.
Ensure all safety reporting obligations to the regulatory authorities for launched products are fulfilled in a timely and compliant manner.
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.