Post-Doctoral Regulatory Affairs Fellow - Product Labeling Operations

Boehringer Ingelheim

  • Ridgefield, CT
  • Training
  • Full-time
  • 6 days ago
DescriptionThe Regulatory Affairs Labeling Operations Fellowship is designed to provide pharmacists with exposure to regulatory requirements for 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 Regulatory leadership, Supply Chain, Distribution, and other stakeholders ensuring all critical timelines are met. This is a unique opportunity to gain expertise in strategic and tactical package labeling while ensuring compliance with applicable regulatory requirements. 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 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 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:
  • Manage projects involving both US marketed products and products in development
  • Provide analysis, advice and guidance on US regulatory labeling topics with a focus on package labeling compliance and new development
  • 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 OR Ph.D. degree in related discipline
  • 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 Requirements1. Curriculum vitae2. 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 & ResponsibilitiesRegulatory 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 package labeling advocate to achieve common goals for assigned projects, with supervision.
With supervision, the RA Labeling Operations Fellow will:
  • Ensure that product artwork meets all health authority regulations, industry standards, company brand requirements and are error-free.
  • Participate in Product Label Review Team meetings for each assigned marketed product and provide functional support for packaging discussions and provide suggestions on prescribing information/patient labeling by identifying and rectifying errors, inconsistencies, and compliance issues, ensuring that documents meet the highest standards of quality and compliance.
  • Coordinate and prepare regulatory labeling documents needed for regulatory labeling submissions.
  • Assist with FDA interactions, such as labeling negotiations, on assigned projects/products.
  • Interact with Global Labeling Artwork Management to ensure high quality artwork is developed and approved in support of the product packaging.
  • Support late-stage development labeling for NCEs/NBEs and labeling supplements initiated by Boehringer Ingelheim, in conjunction with RA Product Labeling Management and the assigned RA Product Manager in the RA Product Groups.
  • Demonstrate proficient and consistently evolving labeling knowledge. Invest substantial time to improve competency level in understanding and interpreting regulations and guidance's, particularly in the area of product and package labeling.
  • Review competitor landscape and assess the impact to packaging labeling for assigned projects/products.
  • Maintain excellent knowledge of applicable corporate/company SOPs, guidelines, and working instructions.
CompensationThis position offers a base salary of $80,0000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please

Boehringer Ingelheim