Postdoctoral Regulatory Affairs Fellow - Product Strategy

Postdoctoral Regulatory Affairs Fellow - Product Strategy Duties & Responsibilities

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.

Regulatory Expertise:

The Fellow will develop basic regulatory strategy expertise/knowledge in one or more therapeutic areas. 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 Product Group Regulatory Affairs Fellow will:

• Regulatory Professionalism:
  • As a regulatory professional with basic knowledge in one or more therapeutic areas, interact effectively at all levels of the organization (local and global), within Regulatory Affairs and across functions, as a US regulatory advocate to achieve common goals for assigned projects.
• RA Subteams and Intra-RA Project Responsibilities:
  • Effectively contribute US operational and strategic perspectives to RA subteam to ensure GRL and the subteam accurately consider US regulatory requirements and challenges in the global context.
  • Present or support review of US-specific regulatory topics to Regulatory Expert Group (REG), as appropriate.
  • Ensure US RA contributions to all local and global project related documentation such as management summaries, TALC / HPSC / DC pre-reads, are clear, complete and accurate, taking on leadership of the information as appropriate.
• Global Project Team Support:
  • In collaboration with the GRL and RA sub-team, provide leadership in the development and implementation of US regulatory strategy within a global development context.
  • Assess US strategic options and provide US regulatory advice to support assigned global development projects and Product Maintenance Optimization strategies, seeking US project team/management alignment as appropriate.
  • Assess opportunities for expedited US regulatory pathways. Define US strategic considerations in the generation of a Global Regulatory Strategy Document.
  • In cooperation with US/Global Labeling, provide project-related US regulatory input into content of the draft CCDS.
  • Provide US guidance to global team on FDA submissions, meetings, and pediatric development requirements including preparation of documentation, as appropriate

The Regulatory Affairs Product Strategy Fellowship is designed to provide pharmacists with exposure to all areas within Regulatory Affairs strategy. 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:

• Act as a company liaison with the US Food and Drug Administration.
• Provide analysis, advice and guidance on US regulatory strategies.
• Research information on regulatory standards and departmental policies.
• Develop expertise on projects in the assigned therapeutic area from the global regulatory, legislative, scientific, medical, pharmaceutical, pharmacovigilance, market access and commercial perspective.

• US-Focused Project Team Support:
  • Provide US regulatory strategic input and advice to US cross-functional teams during development, registration, and marketing approval. Includes, for example, detailed assessment of potential labeling claims to support US commercial activities based on clinical trial design and results, if available, taking into account US regulatory labeling precedence and FDA comments/guidance.
• Pre-evaluations and External Partnerships:
  • Provide broad and well-informed US regulatory leadership to internal and external preevaluations(e.g. Due Diligence) and contribute to assessment reports. For projects witha CRO or licensing partner, provide and implement US RA strategic and operational perspectives/tasks, as appropriate.
• Health Authority Interactions/Submissions:
  • Responsible for all FDA…