(Senior) CMC Regulatory Affairs Manager

OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.

Tasks & responsibilities

 

 

• In this function, you will manage CMC regulatory activities for small molecules in development.
• Further, you will also manage CMC regulatory activities for approved small molecules products.
• You will represent Global CMC Regulatory Affairs on inter-disciplinary strategic projects. Moreover, you maintain up-to-date knowledge and expertise within the global CMC regulatory environment (ICH, FDA, EMA, PMDA, China and Emerging Markets).
• In addition, you will drive acceleration and innovative regulatory strategies.

 

Global management of CMC regulatory tasks and responsibilities in development:

 

 

 

• You will represent the department in global project teams and provide CMC regulatory advice regarding global regulatory requirements, CMC submission strategies and opportunities for seeking scientific advice from health authorities.
• Moreover, you will guide project teams to prepare high quality global registrations documents and response to health authority requests and ensure that timelines will be met.
• You will plan, define, review, and compile global Module 3 documentation for Clinical Trial Applications and Marketing Authorization Applications.
• Furthermore, you will review CMC documentation for in-licensing products.

 

Global management of CMC regulatory tasks and responsibilities during product life cycle:

 

 

• You will represent the department in global project teams and provide regulatory advice regarding global CMC regulatory requirements, CMC submission. strategies and opportunities for seeking scientific advice from health authorities.
• You will guide project teams to prepare high quality global registrations documents and responses to health authority requests.
• You will plan, define, review and compile global Module 3 documentation for post approval CMC activities (e. g. CMC changes and renewals).

 

Requirements

 

 

 

• Master’s degree in life science disciplines like Pharmacy, Chemistry, or Biology or comparable field
• Global CMC regulatory experience in small molecules as well as drug-device combination products
• Experience in CMC development, pharmaceutical production, quality control or quality assurance
• Sound scientific understanding of drug development
• Ability to lead and motivate people in cross-functional teams, set directions and manage changes
• Inter-disciplinary, innovative and strategic thinking
• Strong organizational and communication skills, excellent prioritization and time management skills
• Fluent in English (written and spoken); German language would be a plus

 

Additional requirements for the Senior role:

 

 

 

• Several years’ experience in global CMC regulatory for small molecules as well as for drug-device combination products
• Substantial knowledge of international CMC regulatory requirements (ICH, FDA, PMDA, EU and emerging markets)
• Track record of leading strategic initiatives

 

WHY BOEHRINGER INGELHEIM?

This is where you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area .

Want to learn more about us? Visit https://www.boehringer-ingelheim.com/

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.

READY TO CONTACT US?

Please contact our Recruiting EMEA Team, Tel: +49 (0) 6132 77-173173

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