Regulatory Affairs Job in Delhi
Are you ready to take on a challenging role in regulatory affairs with a leading biopharmaceutical company? Boehringer Ingelheim is seeking a Manager Regulatory Affairs in Delhi to ensure compliance and facilitate product registrations. This Regulatory Affairs Job in Delhi offers the opportunity to work with global teams and make a significant impact in the field.
About Boehringer Ingelheim:
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. The company employs approximately 54,300 individuals serving over 130 markets globally.
Job Details:
- Position: Manager Regulatory Affairs
- Location: Delhi
- Job ID: 34135
Job Description:
The Manager Regulatory Affairs will ensure that all regulatory updates are shared with local and global teams promptly. This role involves taking timely and complete regulatory actions regarding assigned products and therapeutic areas, as well as executing operational regulatory affairs tasks efficiently.
Key Responsibilities in the Regulatory Affairs Job:
- Ensure strategies comply with regulations and liaise with Health Authorities for timely submission and registration.
- Follow up on regulatory approvals for products as per the registration plan.
- Facilitate the earliest submission and approvals for proposed CMC changes as per global timelines.
- Ensure timely renewal to maintain uninterrupted product availability.
- Approve amendments and updates to ensure studies continue and notify relevant parties promptly of updates.
- Follow up on submitted applications with Health Authorities.
- Share all regulatory updates with local and global teams in a timely manner.
- Maintain the RIN database by making entries and impact assessments of relevant updates.
Eligibility Criteria for the Regulatory Affairs Job:
- Bachelor’s degree in medical education.
- 4-6 years of pharmaceutical experience with a regulatory focus in a multinational setting.
- Solid understanding of the D&C Act and Rules.
- Familiarity with working practices at Health Authorities.
- Experience in direct interactions with Regulatory Authorities.
- Strong attention to detail.
- Analytical and communication skills.
- Negotiation skills.
