The Position

We are seeking a dynamic individual to provide global strategic regulatory guidance and leadership throughout the product lifecycle on assigned projects in the Therapeutic Area of CNS, Retinal Health & Emerging Areas (CREA). In this pivotal role, you will develop and be accountable for the Global Regulatory Strategy of your projects lead the Regulatory Excellence Team (RET), and represent Global Regulatory Affairs (GRA) on the Evidence Team (aka the cross-functional project Team).

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

If you want to apply for the position in the US, please use this link: Director, Global Regulatory Strategy Lead (CNS, Retinal Health & Emerging Areas) - Remote (boehringer-ingelheim.com) (https://jobs.boehringer-ingelheim.com/job/Ridgefield%2C-CT-Director%2C-Global-Regulatory-Strategy-Lead-%28CNS%2C-Retinal-Health-&-Emerging-Areas%29-Remote-Unit/1058600001/)

If you want to apply for the position in Germany, click "Apply now".

Tasks & responsibilities

• As a regulatory professional, you will contribute to a holistic global strategy for assigned CREA 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

• High level of education in pharmacy, life sciences, or chemistry, ideally holding a Master's or Doctoral Degree. Additional certifications such as Specialized Pharmacist, Master of Drug Regulatory Affairs, or RAC are highly desirable.

• 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 CREA 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.

Ready to contact us?

If you have any questions about the job posting or process - please contact our HR Direct Team,

Tel: +49 (0) 6132 77-3330 or per mail: hr.de@boehringer-ingelheim.com

Recruitment process:

Step 1: Online application - application deadline is May 15th, 2024

Step 2: Virtual meeting starting in the middle of May 2024

Step 3: On-site interviews starting at the end of May 2024

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.