Exclusive Regulatory Affairs Job at Boehringer Ingelheim | Apply for a Leadership Role!

About the role

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.

Responsibilities

• 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.

Requirements

• 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.

Qualifications

Not specified

Skills

• Strong regulatory expertise.
• Excellent communication and negotiation skills.
• Attention to detail.
• Ability to work independently and as part of a team.

Benefits

Not specified

Pay

Not specified

Schedule

Not specified