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Director, Global Regulatory Strategy Lead (Cardiovascular, Renal & Metabolism) - Remote

Boehringer Ingelheim

Last Updated: 4/15/24

Job Description

Description

This position can be filled in Germany (Ingelheim) or the US.

  • If you want to apply for the position in Germany, please use this link:
  • If you want to apply for the position in the US, click "Apply now".

We kindly ask you to apply for the Boehringer Ingelheim location that is closest to your country of residence. Please, do not apply for more than one location!

*Upon applying for this position, you will encounter a query regarding the visibility of your profile - whether it should be confined to the recruiters managing the jobs you apply to, or be accessible to any company recruiter worldwide. Given that the hiring manager is not based in the country you are applying for and the interview process is performed in the hiring manager country, we kindly urge you to opt for "Any company recruiter worldwide". This action will greatly assist us in processing your application in the most efficient manner, while ensuring compliance with the General Data Protection Regulation.

Duties & Responsibilities

  • As a regulatory professional, you will contribute to a holistic global strategy for assigned CRM projects. Your leadership and in-depth expertise will enable you to interact seamlessly at all levels of the organization, drive project goals, and maintain the highest standards of professionalism, ethics, and regulatory compliance.

  • You will lead the development and implementation of cutting-edge global strategic regulatory strategies. Your role will involve assessing regulatory risks, proposing innovative solutions, and collaborating closely with stakeholders to align regulatory strategies with business objectives.

  • As the main GRA representative on the Evidence Team, you will ensure that regulatory considerations are incorporated timely and comprehensively in the decision-making process.

  • You will lead the Regulatory Excellence Team (RET) for assigned projects, fostering a culture of excellence and continuous learning. Your role will involve mentoring team members, identifying training needs, and promoting a proactive and solution-oriented approach.

  • In collaboration with Asset & Evidence teams and Global Labelling, you will shape early target label profiles and oversee the planning, preparation, and execution of regulatory submissions. Your role will also involve supporting submission rollout for Rest of World (RoW) countries from a global strategic perspective.

  • As a regulatory intelligence expert, you will stay up-to-date with relevant worldwide regulations and guidelines. Your role will involve evaluating evolving regulatory trends, providing timely risk/benefit analyses, and developing contingency plans for assigned projects.

Requirements

  • Bachelor’s degree in pharmacy, life sciences or chemistry with 7 years experience in regulated pharmaceutical industry (biologics or small-molecule)
  • Preferred: Master’s Degree or Doctoral Degree (e.g. PhD) in pharmacy, life sciences or chemistry with 5 years experience in regulated pharmaceutical industry (biologics or small-molecule)
  • Further degrees/certifications: Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification
  • In-depth knowledge of Regulatory Affairs across multiple regions, including the US and/or EU. You have a proven track record of developing and implementing successful regulatory strategies, ideally with preparation of IND, (s)BLA/(s)NDA and/or MAA, Health Authority meeting briefing documents and negotiating with Health Authority(ies) in a major market (e.g. US, EU).

  • Regulatory experience in Cardiovascular, Renal and/or Metabolic diseases is preferred, and experience outside of Regulatory Affairs in R&D will be considered a valuable asset.

  • Proven ability to interpret and translate complex scientific data and regulatory guidelines into project-specific proposals. You should have a commercial awareness and a thorough understanding of the business environment.

  • Strong critical thinking and strategic mindset, with the ability to anticipate both opportunities and challenges in execution. You should excel at problem-solving, decision-making, and developing realistic action plans to achieve specific goals.

  • Excellent leadership and team management skills, with the ability to influence, lead, and inspire cross-functional teams. You should have strong interpersonal skills, relationship building, and conflict management skills.

Compensation

This position offers a base salary typically between $228,000 and $350,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here.



Company Details

Binger Strasse, Germany