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(Senior) Manager Regulatory Affairs CMC

Employer
Boehringer Ingelheim
Location
Ingelheim, Germany
Salary
Competitive
Start date
15 Sep 2022
Closing date
15 Oct 2022

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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


You care about the health of animals? Would you like to use your commitment to support the development and approval of innovative pharmaceutical products? As part of our global Regulatory Affairs team, we offer you diverse and exciting challenges to help drive progress in animal health. Apply now.


Tasks & responsibilities


  • With your expertise in EU pharmaceutical regulations and focus markets, you will define regulatory CMC requirements for initiatives and represent the RA CMC function.
  • As Senior RA CMC Product Manager you will be the central point of contact for internal and external stakeholders regarding technical or regulatory aspects within the life cycle of an assigned product.
  • In addition, you will support the focus markets as well as RA staff responsible for other regions on technical regulatory matters.
  • As Senior Manager for EU Regulatory Affairs, you will be responsible for regulatory activities from pre-submission to completion of the process, including preparation of the regulatory dossier.
  • You will be the contact person for both the EMA and the national regulatory authorities during the European approval procedures.
  • Thanks to your expertise, you define directional regulatory CMC strategies for assigned products and projects.
  • As Regulatory Affairs (RA) project leader / subteam member, your experience enables you to anticipate changes in pharmaceutical legislation and assess the impact on projects and products.
  • Furthermore, you proactively work with regulatory authorities for interpretation of applicable regulations and regulatory strategy.
  • Furthermore, you will represent the company's interests in professional associations and regulatory forums and represent the RA team in internal working groups.



Requirements


  • University degree in life sciences (e.g. pharmacy)
  • Several years of professional experience in regulatory affairs (preferably CMC) or CMC product development
  • In-depth knowledge of regulatory CMC requirements for pharmaceuticals
  • Knowledge of the drug development process (new product development) and life cycle management
  • Several years of experience in direct cooperation with regulatory authorities as well as in representing company interests in professional associations as well as working groups
  • Skills in strategic assessment of new legislation and regulatory trends with regard to product development and product portfolio
  • Effective communication with strong interpersonal skills and analytical approach to solve complex factual and procedural problems
  • High level of initiative, persistence and entrepreneurial thinking
  • Very good command of English



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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Company

With 47,700 employees in 103 countries, Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Since its foundation in 1885, the family-owned company has been pursuing an ambitious goal: to research and develop innovative pharmaceuticals that improve the health and quality of life of humans and animals alike

Company info
Website
Location
Binger Straße 173
Ingelheim am Rhein
55216
Germany

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