Regional Regulatory Lead

The Position

Step into the dynamic world of pharmaceuticals as a Regional Regulatory Lead for EUCAN in Human Pharma. This pivotal role, nestled within our regulatory affairs excellence team, is the driving force behind our development projects and marketed products. As a Regional Regulatory Lead, you will be the expert voice in regulatory requirements for your region, orchestrating and leading interactions with relevant health authorities.

From scientific advice during drug development phases to marketing authorization applications and life cycle maintenance regulatory activities, your expertise will be crucial in delivering robust regulatory strategies for timely submissions, approvals, and compliance.

Join us and make a significant impact on the future of healthcare.

Tasks & Responsibilities

• As the Regional Regulatory Lead for EUCAN in Human Pharma you will provide a robust regulatory strategy for assigned products and/or projects, including guidance on maintenance & development needs in the EUCAN region, pediatric development requirements and clinical trial applications.
• You will plan, coordinate, and oversee regulatory submissions required for maintenance of marketing authorizations in the EUCAN region.
• In collaboration with other related departments, you will organize, schedule, and carry out official in-person and remote meetings with regulatory authorities in EUCAN countries.
• You will contribute as an active member to the Regulatory Excellence Team meetings and other meetings as required, to support development of worldwide regulatory strategies.
• Moreover, you will act as an interface & contact partner for RA functions in ROPUs and OPUs in EUCAN, Global RA and other cross‑functional stakeholders for the assigned marketed products and/or development projects as well as EMA for products under the EU centralized procedure.

Requirements

• Master’s or bachelor’s degree in either pharmacy or life sciences.
• Several years of pharmaceutical industry experience in Regulatory Affairs in Human Pharma; any experience in other functions outside of RA would be highly desirable.
• Regulatory affairs "hands on" experience in the region with an understanding for different cultures and their impact.
• Practical experience in handling new developments, registrations, and maintenance of registered products.
• Outstanding ability in both negotiating and managing projects paired with knowledge of how to interact with health authorities.
• Capability and readiness to apply scientific expertise and participate in informed scientific dialogues.
• A critical thinker who has the aptitude to self‑manage their workload, which includes the ability to reorganize priorities and meet tight deadlines.
• Proficiency in English communication, both verbal and written.

Ready to contact us?

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) or via mail:

Recruitment process

Step 1: Online application – The job posting is presumably online until . We reserve the right to take the posting offline beforehand. Applications up to are guaranteed to be considered. Step 2: Virtual meeting in the period from mid till end of April. Step 3: On‑site interviews beginning of May.

Please submit your application documents in English.

Our Company

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Why Boehringer Ingelheim?

Our company is committed to advancing healthcare worldwide, and we look forward to the unique contributions you will bring to our team.

Want to learn more? Visit