Postdoctoral Fellow Regulatory Affairs - Chemistry, Manufacturing & Control

Boehringer Ingelheim; Ridgefield (CT); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Competitive compensation

Global opportunities

Job summary

Boehringer Ingelheim offers a Clinical Development and Medical Affairs Fellow position at its U.S. headquarters in Ridgefield, CT.

This post-doctoral fellowship provides broad exposure to medical affairs, scientific communications, regulatory affairs, and translational medicine across multiple therapeutic areas. The fellowship includes rotations within or outside assigned areas, exposure to US FDA processes, and opportunities to contribute to regulatory submissions, labeling changes, and

Qualifications

• PharmD degree required or PhD in a related field.
• Ability to perform MEDLINE and EMBASE literature searches.
• Strong interpersonal, listening, and problem-solving skills.
• Excellent verbal and written communication abilities.

Responsibilities

• Develop regulatory expertise across therapeutic areas.
• Coordinate regulatory activities for FDA compliance in US.
• Author, review and update CMC documentation for US products.
• Serve as liaison with FDA and regulatory teams.

Skills

Communication skills

Team collaboration

Problem solving

Fast learner

Education

PharmD degree

PhD in related discipline

Tools

Outlook

Word

PowerPoint

Excel

Job description

The Clinical Development and Medical Affairs Fellow is a post-doctoral pharmacist position that will obtain broad exposure to BI US Medical functions including, but not limited to -- Medical Affairs and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and 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 Regulatory Affairs (RA) Fellowship within the Chemistry, Manufacturing and Controls (CMC) discipline is designed to provide pharmacists with a 2-year exposure to the regulatory aspects of CMC during the lifecycle of BI assets. The selected Fellow will also gain experience coordinating and executing regulatory activities required of an NDA Holder for compliance to FDA requirements for U.S. products in BIPI's commercial portfolio. These responsibilities include management of CMC and product labeling changes as well as the preparation and submission of supplemental applications and post-marketing reports per US regulations.

The Fellow will be exposed to projects involving both US marketed products and early phase US INDs. Under supervision, the Fellow will:

• Act as a company liaison with the US Food and Drug Administration.
• Research information on regulatory CMC standards and departmental policies.
• Provide strategic regulatory input as it pertains to US Marketed Products
• Author, review and update CMC documentation for US registered products.

Description

The Clinical Development and Medical Affairs Fellow is a post-doctoral pharmacist position that will obtain broad exposure to BI US Medical functions including, but not limited to -- Medical Affairs and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and 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.

Duties & Responsibilities

Regulatory Expertise

The Fellow will develop basic regulatory expertise/knowledge in one or more therapeutic areas covering multiple dosage forms while interacting effectively within Regulatory Affairs and across CMC stakeholder functions, as a regulatory advocate to achieve common goals for assigned projects.

Position Expertise

Basic knowledge of pharmacy gained through Doctor of Pharmacy program

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 feedbackAbility 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

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