Boehringer Ingelheim

Regional Regulatory Lead

Boehringer Ingelheim

full-time

Posted on:

Location Type: Office

Location: Austria

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Job Level

Senior

About the role

  • 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

  • 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
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

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