Postdoctoral Regulatory Affairs Fellow - Product Labeling Content

Boehringer Ingelheim; Ridgefield (CT); On-site; USD 60,000 - 80,000; Full time

Job summary

Boehringer Ingelheim is offering a Regulatory Affairs Labeling Content Fellowship based at its U.S. headquarters in Ridgefield, CT.

The program provides pharmacists with exposure to US regulatory labeling and rotations within and beyond Regulatory Affairs to build competencies across therapeutic areas such as cardiology, diabetes, immunology, oncology, and respiratory. As an employee, you will contribute to discovery, development, and delivery of products while gaining insight into a global

Qualifications

• Doctor of Pharmacy degree from ACPE-accredited school or college.
• Strong intrapersonal, active listening, and problem-solving skills.
• Excellent verbal and written communication skills.
• Ability to work independently within provided guidance from team leads.

Responsibilities

• Chair meetings of the Product Label Review Teams (PLRT) for each marketed product. Draft/revise product labeling and compile supportive documentation.
• Coordinate preparation of regulatory labeling documents needed for submissions with other departments.
• Assist with FDA interactions on assigned projects and ensure consistency with CCDS proposals.

Skills

Communication skills

Team collaboration

Problem solving

Education

Doctor of Pharmacy degree (ACPE-accredited)

Tools

Outlook

Word

PowerPoint

Excel

Job 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, 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, and guidance on US regulatory labeling strategies and content of labeling.
• Research information on regulatory labeling standards and departmental policies.

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, 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, and guidance on US regulatory labeling strategies and content of labeling.
• Research information on regulatory labeling standards and departmental policies.

Requirements

• Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy OR Doctor of Philosophy (PhD) degree in related discipline 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.)

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 representative 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 Sr Leadership 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.

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com