Post Doctoral Regulatory Affairs Fellow - Product Strategy

Duties & Responsibilities

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

Description

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 & Responsibilities

• 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 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

Application Requirements

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.

Requirements

• Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned prior to the start date at Boehringer Ingelheim.
• Ability to perform MEDLINE and EMBASE literature searches.
• Strong intrapersonal, active listening, and problem-solving skills with an ability to work well in a team environment.
• Highly motivated and shows initiative in contributing to team deliverables.
• Receptive to receiving and quickly implementing constructive feedback.
• Ability to work independently within provided guidance from team leads.
• Adaptable and able to contribute to multiple Therapeutic Areas as needed.
• Excellent verbal and written communication skills.
• Proven experience working in a dynamic, high volume environment handling multiple tasks.
• Strong computer skills, including Outlook, Word, PowerPoint, and Excel.
• Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy with an ability to quickly adapt to a changing Corporate environment that will allow the incumbent to be productive in rotational experiences.

Desired Experience, Skills, and Abilities:

• Prior pharmaceutical industry experience (e.g. internship or Advanced Pharmacy Practice Experience [APPE] rotation is preferred but not required.)

Compensation

This position offers a base salary of $80,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here.