Global CMC Manager Regulatory Affairs (fixed term) at Boehringer Ingelheim

Posted 1 week ago

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.

THE POSITION

Our mission within the department is to promote the business of Boehringer Ingelheim by acting as a worldwide center of excellence and service for CMC regulatory aspects. We are committed to support strategic company projects requiring CMC regulatory expertise. We anticipate global CMC regulatory trends to support the approvals for all regulatory submissions in optimal time. We also support and maintain CMC regulatory systems and tools.
Your responsibilities will cover CMC regulatory activities for both, development project and maintenance of registered products.
This position is currently only available on a two-year fixed-term contract.

Tasks & responsibilities

In this function, you represent Global CMC Regulatory Affairs on general, inter-disciplinary strategic projects and represent BI on external industry groups. Moreover, you maintain up-to-date knowledge and expertise within the global CMC regulatory environment (ICH, FDA, EMA, PMDA and Emerging Markets).
You contribute to development, innovation and continuous improvement of processes and standards within Regulatory Affairs.
Global management of CMC regulatory tasks and responsibilities in development as well as during product life cycle:
  • In this role, you represent the department in international project teams and provide CMC regulatory and/or regulatory advice regarding global (CMC) regulatory requirements, CMC submission strategies and opportunities for seeking scientific advice from health authorities.
  • It is your responsibility to guide project teams to prepare high quality global registrations documents and responses to health authority requests and ensure that timelines will be met.
  • In addition, you plan, define, review and compile global Module 3 documentation for Clinical Trial Applications, Marketing Authorization Applications as well as for post approval CMC activities (e.g. CMC changes and renewals).
  • Furthermore, you will review CMC documentation for in-licensing products.

Requirements

  • Master in Biotechnology, Biochemistry preferred. Alternatively, Master in Pharmacy, Chemistry, Biology with relevant work experience required
  • In depth global CMC regulatory experience (with focus on EU, US) for small molecules, biologicals and/or ATMPs as well as for drug-device combination products
  • Experience in CMC development and/ or production/control of small molecules, biologicals and /or ATMPs with sound scientific understanding of products and processes
  • Inter-disciplinary, innovative and strategic thinking
  • Strong communication and organizational skills; with the ability to work both independently and within a team structure
  • Risk identification and problem solving skills
  • Fluent in English (written and spoken); German language skills would be a plus

EFFECTS OF COVID-19

We will continue to hire talented people and we look forward to receiving your applications. As a result of COVID-19, we have introduced alternative working arrangements to ensure that our employees can stay safe and healthy, because the health of our employees is among our top priorities. At all company locations, we work remotely whenever possible. Additionally, we are now hosting virtual video interviews for applicants. During the limited in-person interviews we still have during this time, we pay special attention to distance and the hygiene rules recommended by the Robert Koch Institute. New employees who do not start on site in production or the laboratories are sent the necessary IT equipment, our Welcome Days take place online, and we plan to conduct their onboarding training virtually whenever possible.

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 .
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: Mareike Schönberg, Tel: +49 6132 77 171571.
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Job

  • Regulatory

Primary Location

  • Europe-DE-Rhineland-Palatinate-Ingelheim

Other Locations

  • Europe-DE-Baden Wuerttemberg-Biberach

Organization

  • DE-BI International GmbH

Schedule

  • Full-time>
    • Full-time>

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