Amgen Regulatory Affairs Job Vacancies – Senior Associate Regulatory Affairs
Are you a seasoned professional in the field of Regulatory Affairs? Amgen, a leading biotechnology company, is offering an exciting opportunity for a Senior Associate, Regulatory Affairs based in Mumbai, India. With our focus keyword “Amgen Regulatory Affairs Job Vacancies,” we aim to optimize your content for higher visibility on Google rankings.
About Amgen
Amgen, a pioneer in biotechnology advancements, has been delivering groundbreaking medicines to patients worldwide for over four decades. With a commitment to innovation and cutting-edge manufacturing capabilities, Amgen has made significant contributions to the biotech industry.
Senior Associate, Regulatory Affairs
Location: Mumbai, India
Role Overview
As a Senior Associate, Regulatory Affairs, you will play a vital role in ensuring compliance with local regulatory requirements and aligning them with Amgen’s corporate standards. Your responsibilities will include:
- Assisting in aligning local regulatory requirements with Amgen’s corporate standards.
- Contributing to the filing plan (Marketing Authorization and Lifecycle maintenance) and implementing it for the country.
- Providing input and implementing regulatory strategies for the country or region.
- Leading local regulatory submissions in adherence to corporate standards and local regulations.
- Developing and maintaining local labels in accordance with local legislation and Amgen’s standards.
- Acting as the point of contact with regulatory agencies.
Qualifications and Experience
- Degree in Life Sciences, Pharmacy, or a Biomedical field.
- 3-5 years of relevant regulatory experience.
- Strong knowledge of regulatory principles, policies, procedures, and SOPs.
- Comprehensive understanding of regulatory activities and their impact on projects and processes.
- Familiarity with Indian regulations related to new product registration, lifecycle management, clinical trials, and the SUGAM portal.
- Awareness of registration procedures and challenges in the country for CTAs, MAs, and lifecycle management.
- Understanding of the regulatory environment in the country relevant to the product area and development stage.
- Knowledge of drug development processes.
