TN Visa Senior Director Regulatory Affairs Jobs

INTRODUCTION

The Regulatory Affairs (RA) Labeling Operations Fellowship is designed to provide pharmacists with exposure to FDA regulations, guidance, and other regulatory requirements applicable to U.S. package and product labeling. The position offers an opportunity to be involved in critical matters related to operational labeling implementation, strategy, and compliance in collaboration with senior RA leadership, Supply Chain, Distribution, and other stakeholders, ensuring all critical timelines are met. This is a unique opportunity to gain expertise in strategic planning and operational implementation of package labeling while ensuring compliance with applicable regulatory requirements.

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 in multiple therapeutic areas such as 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 opportunities for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the company’s 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.

ROLE AND RESPONSIBILITIES

The fellow under supervision will:

• Manage defined projects involving both U.S. marketed products and products in development.
• Apply FDA requirements and internal procedures to U.S. package and labeling activities.
• Research emerging regulatory labeling requirements and communicate their potential operational impact.

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 the ability to work well in a team environment.
• Highly motivated, with demonstrated initiative in contributing to team deliverables.
• Receptive to receiving and quickly implementing constructive feedback.
• Ability to work independently within established guidance and seek direction when appropriate.
• Adaptable and able to contribute to multiple therapeutic areas as needed.
• Excellent verbal and written communication skills.
• Demonstrated ability to prioritize competing assignments and meet established timelines in a dynamic, high-volume environment.
• Strong computer skills, including Outlook, Word, PowerPoint, and Excel.
• Foundational understanding of pharmaceutical development, corporate functions, and regulatory considerations, with the ability to adapt quickly and contribute productively across rotational assignments.
• Strong attention to detail and commitment to quality.
• Ability to interpret and apply regulations, guidance, and internal procedures.

PREFERRED QUALIFICATIONS

• Prior pharmaceutical industry experience, such as an internship or Advanced Pharmacy Practice Experience (APPE) rotation, is preferred but not required.
• Experience with or exposure to artificial intelligence tools, specialty pharmacy, supply chain, or regulated document-management processes is preferred but not required.

APPLICATION REQUIREMENTS

1. Curriculum vitae

2. Letter of intent describing how the fellowship aligns with the applicant’s career goals and how the applicant’s background would contribute to the program. Please upload the letter under My Documents, Additional Attachments.

DUTIES & RESPONSIBILITIES

Regulatory Expertise:

The fellow will develop foundational regulatory labeling knowledge and expertise across one or more therapeutic areas. With supervision, the fellow will collaborate effectively within Regulatory Affairs and across functions, serving as a U.S. package and labeling representative for assigned projects.

With supervision, the RA Labeling Operations fellow will:

• Support the end-to-end development, review, approval, implementation, and maintenance of compliant U.S. labeling and packaging artwork.
• Support labeling change control activities, track deliverables and implementation timelines, and identify or escalate potential compliance risks, inconsistencies, or delays.
• Ensure that product packaging artwork meets all FDA regulations, industry standards, company brand requirements and are error-free.
• Participate in Product Label Review Team meetings for assigned products and provide functional support for packaging and labeling discussions, helping ensure that documents meet quality and compliance standards.
• Coordinate and prepare regulatory labeling documents in support of regulatory labeling submissions.
• Participate in FDA labeling negotiations by supporting the preparation and coordination of responses to FDA questions related to labeling and packaging.
• Collaborate with cross-functional stakeholders to support the development, review, approval, and implementation of accurate, compliant packaging artwork.
• Continuously build proficiency in interpreting and applying regulations, guidance, and internal procedures related to product and package labeling.
• Monitor the competitive and regulatory landscape and assess potential implications for labeling components associated with assigned products or projects.
• Collaborate with Regulatory Affairs, Quality, Supply Chain, Packaging, Distribution, Global Labeling Artwork Management, and other stakeholders to support timely and compliant labeling implementation.
• Maintain accurate labeling documentation and records in applicable document-management, artwork, and regulatory-tracking systems in accordance with company procedures.
• Maintain excellent knowledge of applicable corporate/company SOPs, guidelines, and working instructions.

COMPENSATION