Postdoctoral Regulatory Affairs Fellow - Product Strategy

Regulatory Affairs Product Strategy Fellowship

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.

Additional duties and responsibilities include:

• US-Focused Project Team Support:
• Provide US regulatory strategic input and advice to US cross-functional teams during development, registration, and marketing approval.
• 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 with a CRO or licensing partner, provide and implement US RA strategic and operational perspectives/tasks, as appropriate.
• Health Authority Interactions/Submissions:
• Responsible for all FDA interactions on assigned projects/products, including formal meetings, FDA review of registration packages, and labeling negotiations.
• Establish and implement US regulatory strategy and goals for formal meetings with FDA that is aligned with project teams and RA Subteam.
• Provide regulatory leadership to ensure alignment with global and US team/management, as appropriate, in preparing responses to FDA requests.
• Lead FDA meetings for assigned projects
• Disseminate FDA interactions within BI, as appropriate.
• Manage all formal submissions and informal communications to FDA for assigned projects/products, including clinical trial and marketing authorization applications.
• Other Regulatory Contributions:
• Provide US strategic regulatory guidance and input to key internal development, registration and commercialization documents for assigned projects (e.g. development plans, protocols, clinical trial reports, pediatric development plans, core dossier elements, integrated brand plans, market access documents, with particular emphasis on the US contribution within the strategic country prioritizations (i.e., "hyperfocus")).
• Provide US regulatory leadership with preparation, content, and distribution in the US of critical safety or quality communications (including DHCP letters) for assigned projects/products, with guidance from management, GRL, US Legal, and GPV, as appropriate.
• As defined by respective BI processes, review and release, via cross-functional medical legal-regulatory team, US core messages, as appropriate (e.g., press release, stand-by statements).
• Regulatory Intelligence:
• Proactively review and evaluate relevant US regulations and guidelines, as well as evolving regulatory trends and developments for their impact on drug development activities and on existing development strategies.
• Share new/novel "on the job" US regulatory intelligence/experience with peers, as appropriate

1. Curriculum vitae

2. Letter of intent - focusing on how a fellowship at Boehringer Ingelheim can help further your career growth.
* Please upload under My Documents, Additional Attachments.

• Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned prior to the start date at Boehringer Ingelheim OR Ph.D. degree in…