Sr. Associate Regulatory Affairs in Mumbai at Amgen
Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Senior Regulatory Affairs in Mumbai, India.
Senior Associate, Regulatory Affairs
Location: Mumbai, India
The Local Regulatory Representative (Sr. Associate) is assigned to one or more Amgen products and may support a LRR or lead a program under the supervision of an experience Local Regulatory Lead. The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.
- Assist in aligning local regulatory requirements with Amgen’s corporate standards.
- Contribute for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team. With close supervision, implementing the filing plan (MA and Lifecycle maintenance) for the country(ies), where applicable.
- Provide country specific / regional (as applicable) input to and implement regulatory strategies.
- Plan and lead local regulatory submissions in compliance with corporate standards and local regulatory requirements.
- Provide guidance on local mechanisms to optimize product development and regulatory approvals.
- Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
- Act as the point of contact with regulatory agencies.
- Degree in LifeSciences, Pharmacy or Biomedical field and 3-5 years of relevant regulatory experience
- Knowledge of Regulatory principles.
- Working with policies, procedures, and SOP’s.
- Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
- Good knowledge of Indian regulations on new product registration, lifecycle management and clinical trials, SUGAM portal handling.
- General awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
- Knowledge and experience in the country(ies) regulatory environment relevant for product area and development stage.
- Understanding of drug development.
What We Offer
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply Online: Link
Keywords: Sr. Associate Regulatory Affairs, Mumbai, Amgen, Apply Online