Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Post : Manager- Regulatory Affairs
Job Description:
• 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
• 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
Candidate Profile
• Education: Bachelor’s degree or Master degree in Life Sciences or equivalent or B Pharm or M Pharm
• Minimum 6 years of solid experience in Regulatory affairs with experience in domestic regulations (India registration) is must. Experience in the working in multinational matrix organization is must.
• CMC specific regulatory knowledge and experience; Clinical Application and market applications (MAAs or variations).
• Strong oral and written communication skills.
Additional Information:
Location: Mumbai
Auto req: R-47820
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs
End Date: 10th May, 2018
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