Postdoctoral Regulatory Affairs Fellow - Policy and Intelligence

Clinical Development And Medical Affairs Fellow

The Clinical Development and Medical Affairs Fellow is a post-doctoral pharmacist position that will obtain broad exposure to BI US Medical functions including, but not limited to -- Medical Affairs and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position will require the Fellow to develop competencies necessary to contribute to their respective functional area within a pharmaceutical company.

The Fellow will be based at Boehringer Ingelheim´s U.S. headquarters in Ridgefield, CT, working on a particular or multiple therapeutic areas (TAs) in the areas of cardiology, diabetes, immunology, oncology, and respiratory and mental health. Through a series of rotations either within or outside of the assigned area, the Fellow will also gain an understanding of the broad range of opportunities available to a pharmacist in the pharmaceutical industry.

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, mobility, networking and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees. The Regulatory Policy and Intelligence Fellowship is designed to provide pharmacists with exposure to regulatory intelligence and policy activity within the pharmaceutical industry. The position will also offer the opportunity to complete rotations in areas within and beyond Regulatory Affairs. The Fellow will be exposed to projects involving both US marketed products and investigational projects.

Under supervision, the Fellow will:

• Develop, compile, and integrate regulatory intelligence from health authorities, professional groups, publicly available information and BI.
• Appropriately communicate regulatory intelligence within the organization.
• Provide analysis, advice, and guidance on US/Global regulatory strategies to promote expedited product development and approval.
• Research information on regulatory policies and departmental policies within and external to RA.
• Research and implement processes to improve regulatory intelligence and collaboration.
• Develop expertise on projects from the regulatory intelligence and policy perspective.
• Collaborate with BI Government Affairs to ensure knowledge sharing of overlapping intelligence topics.

Regulatory Expertise:

The Fellow will develop basic regulatory policy and intelligence knowledge across the spectrum of BI assets and marketed products. Interact effectively within Regulatory Affairs and across functions, as a US regulatory advocate to achieve common goals for assigned projects, with supervision.

With supervision, the Regulatory Policy and Intelligence Fellow will:

• Proactively review and evaluate relevant US regulations and guidelines, as well as evolving regulatory trends and developments for their impact on drug and device development activities and on existing development strategies.
• Lead requests for global country-level regulatory information from various partners.
• Handle the development of custom reports to support regulatory compliance and advise strategy.
• Collaborate with partners to support any compliance and process initiatives.
• Own the review and refinement of regulatory FDA guidance and…