Job Title: Sr. Associate Regulatory Affairs
Company: Amgen
Location: Mumbai, India
Amgen is one of the world’s leading independent biotechnology companies, known for pioneering biotechnology breakthroughs to bring state-of-the-art medicines from the laboratory to the patient. With over 40 years of experience, Amgen has not only discovered and developed innovative human therapeutics but has also invested in cutting-edge manufacturing capability and support services. We are currently experiencing significant growth in Japan and the Asia Pacific region. To support our expanding operations, we are looking to hire a Senior Associate Regulatory Affairs in Mumbai, India.
About the Role:
As a Senior Associate Regulatory Affairs at Amgen, you will play a key role in ensuring compliance with local regulatory requirements and implementing regulatory strategies. You will be responsible for aligning local regulatory requirements with Amgen’s corporate standards, planning and leading local regulatory submissions, and serving as the point of contact with regulatory agencies. This is an exciting opportunity to contribute to the development and approval of innovative therapies.
Key Responsibilities:
- Assist in aligning local regulatory requirements with corporate standards
- Contribute to the filing plan for marketing authorizations and lifecycle maintenance
- Provide country-specific/regional input and implement regulatory strategies
- Plan and lead local regulatory submissions in compliance with corporate standards and local requirements
- Guide product development and regulatory approvals through local mechanisms
- Develop and maintain local labels in compliance with legislation and company standards
- Act as the primary contact with regulatory agencies
Qualifications:
- Degree in Life Sciences, Pharmacy, or a related field
- 3-5 years of relevant regulatory experience
- Knowledge of regulatory principles and familiarity with policies, procedures, and SOPs
- Comprehensive understanding of regulatory activities and their impact on projects and processes
- Good knowledge of Indian regulations on new product registration, lifecycle management, and clinical trials
- Familiarity with SUGAM portal handling and general awareness of registration procedures and challenges
What We Offer:
At Amgen, we prioritize the professional and personal growth of our team members. You can expect:
- Vast opportunities for learning and career advancement within our global organization
- A diverse and inclusive community where ideas are encouraged and valued
- A generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Keywords: Sr. Associate Regulatory Affairs, Mumbai, Amgen, biotechnology, pharmaceutical, regulatory requirements, regulatory strategies, compliance, marketing authorizations, lifecycle maintenance, local labels, regulatory agencies, clinical trials, career growth, Total Rewards Plan
