Global Regulatory Strategy Lead (Biberach, Germany, Baden-Württemberg)
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The Position
We are seeking a dynamic individual to provide global strategic regulatory guidance and leadership throughout the product lifecycle on assigned projects. 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 different countries.
If you want to apply for the position in the US, please use this link: ’ Director, Global Regulatory Strategy Lead (Eye Health) - Remote Job Details | BoehringerPRD ’
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 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 Brand & 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.
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 one or several of Boehringer Ingelheim’s Therapeutic Areas is preferred, and experience outside of Regulatory Affairs, e.g. in Clinical Development and 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 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, team management and communication skills, with the ability to influence, lead, and inspire cross-functional teams. You should have strong interpersonal skills, relationship building, and conflict management skills, combined with excellent English skills
As part of our commitment to transparency and fairness, salary information will be shared during the recruitment process. We also offer a comprehensive benefits and wellbeing package.
Applications from persons with severe disabilities are warmly welcomed. In cases of equal qualifications, such applicants will be given preferential consideration in the selection process.
Ready to contact us?
Do you have any questions about the job posting or the next steps? You can find everything you need to know about the application, hiring, and internal transfer process here. If you have any further questions, please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com
Please submit your application documents in English.
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 546 comparable Regulatory Affairs roles across 116 biopharma companies.
Salary context
132 of 546 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 546 comparable roles
+ 41 more countries
Seniority mix
440 of 546 peers have a known seniority level
Therapeutic area mix
54 of 546 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Open in 2 locations
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.