Regional Regulatory Lead

Boehringer Ingelheim

Regional Regulatory Lead overseeing EUCAN regulatory strategy for pharmaceutical projects and products. Planning submissions, coordinating meetings, and collaborating with regulatory authorities.

Posted 4/20/2026full-time🇦🇹 AustriaSeniorWebsite

About the role

Key responsibilities & impact

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.
Plan, coordinate, and oversee regulatory submissions required for maintenance of marketing authorizations in the EUCAN region.
Organize, schedule, and carry out official in-person and remote meetings with regulatory authorities in EUCAN countries.
Contribute as an active member to the Regulatory Excellence Team meetings and other meetings as required, to support development of worldwide regulatory strategies.
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

What you’ll need

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.

Benefits

Comp & perks

Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategyregulatory submissionsclinical trial applicationspediatric development requirementsproduct registrationsmaintenance of marketing authorizationsscientific expertiseproject managementnegotiation skillscritical thinking

Soft Skills

self-managementability to reorganize prioritiesmeeting tight deadlinesinterpersonal communicationcross-functional collaborationcultural awarenessactive participationorganizational skillsverbal communicationwritten communication

Certifications

Master's degree in pharmacyBachelor's degree in life sciences