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Global Regulatory Lead

Employer
Boehringer Ingelheim
Location
Ingelheim, Germany
Salary
Competitive
Start date
29 Mar 2023
Closing date
28 Apr 2023

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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

For our Product Group CardioMetabolic Respiratory and Established Products withinour Global Department Drug Regulatory Affairs, we are seeking to recruit a Global Regulatory Lead.

Tasks & responsibilities

As a Global Regulatory Lead (GRL) you will:

 

  • Provide global strategic regulatory guidance to the Evidence Team and other cross functional teams, challenge development/PMO programs scientifically and manage all regulatory aspects through the development of new medicinal products, new indications or PMO projects and the maintenance period.
  • Provide as a member of a Global Device Team the global regulatory input for developments of a Software as a Medical Device or Device.
  • Lead Regulatory Excellence Team of global drug or device projects, potentially with the involvement of licensing partners.
  • Develop and implement sound regulatory strategies and provide regulatory advice to support assigned projects.
  • Define, provide guidance and input as well as review of key regulatory documents needed for drug and any kind of Device developments and determine the need for external advice.
  • Coordinate interaction with Health Authorities / Notified Bodies.
  • Maintain global oversight of local RA activities to assigned projects, providing global regulatory guidance and input as appropriate.
  • Follow regulatory standards, provide analysis, advise on and implement regulatory strategies and departmental policies and utilize resources consistent with the overall goals and objectives of the GRA department as well as keep up to date on developments in the assigned therapeutic area from the global regulatory, scientific, pharmaceutical, pharmacovigilance, market access and commercial perspective.

 


Requirements

 

 

 

  • Doctoral or master’s degree in life sciences; further degrees (e.g. Specialized Pharmacist or Master of Drug Regulatory Affairs) are welcome
  • Several years of experience in the pharmaceutical industry with in-depth knowledge in RA, preferably with Cardio Metabolic Respiratory and Device experience, gained through direct regulatory liaison in at least one major region
  • Critical thinker with ability to self-direct workload, including reprioritizing and delivery under tight timelines
  • Ability to analyze and interpret scientific data and regulatory guidelines
  • Leadership, sound decision-making, negotiation and problem-solving skills in an independent manner with an overall strategic view and a strong business acumen
  • Demonstrated understanding of the regulatory process and technical competence in core areas of drug development
  • Excellent oral and written communications skills (in English language) with the ability to provide key messages in a concise manner

 


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

Not exactly the position you are looking for but have someone else in mind? Share it via the button on the bottom of the page with friends or colleagues who might be interested.

 

 

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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