Postdoctoral Regulatory Affairs Fellow – Product Strategy Full-time

Regulatory Affairs Product Strategy Fellowship

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 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.

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.

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 OR Ph.D. degree in related discipline.
• 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.