For assigned development projects and US marketed products, provide experienced US regulatory leadership to the global and US cross-functional teams. Provide US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance.
- Act as primary company liaison with the US Food and Drug Administration.
- Provide analysis, advice and guidance on US regulatory strategies.
- Provide expertise on regulatory standards and departmental policies.
- Utilize resources consistent with the overall goals and objectives of the (G)RA department.
- Maintain current expertise on developments in the assigned therapeutic area from the global regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance, market access and commercial perspective.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Requirements
- Bachelor's Degree in life sciences, pharmacy, or chemistry from an accredited institution, with extensive drug development experience/knowledge.
- Doctoral Degree (e.g. PhD) and/or Master's Degree in life sciences, pharmacy, or chemistry, with some drug development experience/knowledge preferred.
- RAC certification preferred.
- Five (5) years of experience in regulated pharmaceutical industry (biologics or small-molecule).
- Requires a robust and broad range of US regulatory experience and knowledge, from both strategic and operational perspectives.
- Solid understanding of BI processes and culture.
- Solid scientific, pharmaceutical, and medical background.
- Medical, pharmaceutical and scientific knowledge and understanding in the assigned therapeutic area. Extensive experience demonstrated in managing all aspects of FDA liaison activities (e.g., submission strategies, FDA meeting, AdComm participation/leadership).
- Critical thinker with ability to self-direct workload, including reprioritizing and delivery under tight timelines.
- Ability to analyze and interpret scientific data and regulatory guidelines.
- Strong interpersonal skills supporting the ability to influence without authority, develop effective professional relationships, work in a matrixed team environment, and demonstrate sound conflict management and negotiation skills along with the flexibility and willingness to adapt to a changing environment.
- Leadership, sound decision-making, negotiation and problem solving skills in an independent manner with an overall strategic view and a strong business acumen.
- Excellent oral and written communications skills with the ability to provide key messages in a concise manner.
- Excellent meeting preparation and presentation skills.
- Demonstrated understanding of the regulatory process and technical competence in core areas of drug development.
- (In-depth) knowledge in RA gained through direct regulatory liaison with US FDA Understanding of and fluency with:
- Food, Drug and Cosmetic Act.
- 21 CFR regulations relevant to drug/biologic development and registration.
- Other relevant US laws, regulations and guidance documents.
Desired Skills, Experience and Abilities
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