Senior Associate Director, Global Regulatory Affairs CMC -NCE​/NBE

Are you ready to take on a pivotal role with worldwide responsibility for CMC-regulatory aspects across strategic approved products, development projects and high-impact strategic projects? Within our Global CMC Regulatory Affairs Group, we are looking for an expert to lead initiatives that demand extraordinary regulatory expertise and strategic vision. In this role, you will support complex, non-standard projects involving multiple indications and formulations, often in collaboration with licensing partners.

As a trusted expert, you will monitor developments in strategically important areas, assess their impact on Boehringer Ingelheim, and provide critical insights to colleagues in Regulatory Affairs and other key functions. This is your opportunity to shape the future of regulatory excellence at BI while driving innovation and ensuring compliance in a dynamic, global environment. Are you ready to make a difference?

Take the next step in your career and help us shape the future of data governance!

• Represents the global CMC regulatory affairs function in support of development projects; including accelerated development scenarios.
• Provides the worldwide consolidated opinion and advice on CMC regulatory requirements and topics (including review of CMC documents), during the development from Start of Development until registration.
• Establishes, maintains, and enhances CMC regulatory expertise via knowledge management, training, monitoring of regulatory trends, etc.
• Possesses and maintains knowledge of ICH, FDA, EU, JP and CN guidelines, as well as emerging markets, and monitors and understands upcoming regulatory trends.
• Analyzes regulatory guidance and identifies the relevance and impact to the Company’s development projects/ registered products.
• Reviews, coordinates and comments on proposed CMC related guidelines including regulatory initiatives/actions from ICH, FDA, EMA and other countries as appropriate.
• Enhances regulatory CMC expertise and awareness through the creation, storage and sharing of CMC RA knowledge both within Global CMC RA and with relevant external stakeholders.
• Represents Global CMC RA in relevant BI internal project teams and external project teams where regulatory CMC topics both for development and product life cycle management are concerned.
• Serves as deputy to Head of Global CMC RA for corporate Change Control matters.
• Ensures that CMC regulatory requirements for variations are available in the change management system (Global Variation Database) and supports the CMC Change Coordinator in providing worldwide regulatory assessment of change applications, the Global Variation Database coordinator is responsible for the maintenance of the database.
• Collaborates with the GRA responsible for Training & Compliance and provide CMC relevant input regarding the assignment of procedures within the department.

• Represents the worldwide CMC regulatory affairs function in support of lifecycle management activities for non-standard international products with high complexity and high business impact, e.g., drug-device combinations, formulation changes and transfers.
• Provides worldwide consolidated CMC regulatory strategy (including review of documentation) and ensures that global CMC regulatory requirements are met during the product life cycle of internationally registered products.

• Required:
  
  Minimum BS/BA Chemistry, Biology, Pharmaceutical Science or relevant field of study. An advanced degree is preferred.
• With BS/BA:
  Min eight (8) years regulatory work experience in pharma industry, health authorities, or equivalent experience required.
• With M.S.:
  Min six (6) years’ work experience in pharma industry, health…