Post Doctoral Regulatory Affairs Fellow - Product Labeling Content

Description

The Regulatory Affairs Labeling Content Fellowship is designed to provide pharmacists with exposure to regulatory requirements for US product labeling. The position will also offer the opportunity to complete rotations in areas within and beyond 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. 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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

The Fellow, under supervision, will be exposed to projects involving both US marketed products and investigational projects. Under supervision, the Fellow will:
• Provide analysis, advice and guidance on US regulatory labeling strategies.
• Research information on regulatory labeling standards and departmental policies.

Requirements

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

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.

Duties & Responsibilities

Regulatory Expertise:
The Fellow will develop basic regulatory labeling expertise/knowledge in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a US regulatory labeling advocate to achieve common goals for assigned projects, with supervision.

Duties & Responsibilities

• Chair meetings of the Product Label Review Teams (PLRT) for each assigned marketed product. Provide functional support for discussions such as the Annual Labeling Review, Company Core Data Sheet (CCDS) Updates, and other ad hoc issues (e.g., FDA requests for labeling changes). Draft/revise product labeling and compile supportive documentation as part of PLRT. Ensure each marketed product’s labeling aligns with the company’s CCDS and local health authority regulations and guidelines. Prepare documentation before meetings, identify issues for discussion, prepare meeting minutes, and follow up on outstanding issues.
• Bring PLRT proposals to the Product Labeling Committee (PLC) for discussion, review, and approval as required. Coordinate preparation of regulatory labeling documents needed for submissions with other departments (e.g., RA Product Labeling Operations, RA Operations, and RA Product Groups). Review Labeling Content deliverables for submissions for completeness, consistency, and accuracy, making recommendations to PLRTs or RA Product Managers as appropriate. Review labeling sections of NDA Annual Reports, PADERs, and PBRERs.
• Assist with FDA interactions on assigned projects/products, including labeling negotiations. Interact with Global Labeling (GL) before major US labeling changes to ensure consistency with company core labeling or the need for revisions. Advise on the suitability of CCDS proposals for US implementation, provide impact assessments on US labeling, and liaise with PLRT to facilitate US-specific feedback and needs into Global RA sub-teams.
• Demonstrate proficient and evolving labeling knowledge. Invest time to improve competency in understanding and interpreting regulations and guidances, particularly in product labeling. Review regulatory developments with RA Product Labeling Groups and keep BI updated on changes in the US regulatory environment impacting product labeling. Maintain excellent knowledge of applicable corporate/company SOPs, guidelines, and working instructions.
• Support late-stage development labeling for NCEs/NBEs and labeling supplements initiated by BI, in conjunction with RA Product Labeling Management and the assigned RA Product Manager in the RA Product Groups.