Associate Director, DRA Product Labeling Content (On-site/Hybrid)

The AD, Regulatory Affairs Product Labeling Content: Leads and manages the coordination of activities of labeling matters for assigned products including independently chairing Labeling sub team meetings and providing substantial functional support for discussions, drafting/revising product labeling (US Prescribing Information) and compiling supportive documentation in line with Company Core Data Sheet (CCDS) in a manner consistent with US labeling regulations and guidance. Brings Labeling sub team proposals to Leadership Committee for review as required. Supports development labeling for NCEs/NBEs and labeling supplements. With minimal assistance from senior labeling management, from a labeling perspective, provides impact assessment on US labeling. Continuously identifies needs and develops and/or maintains local procedures to support labeling initiatives in compliance with Corporate and local regulatory requirements. The AD also provides training to cross-functional colleagues and within Labeling Content, as appropriate, for labeling related procedures.

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

• Independently chair Labeling sub team meetings for assigned products and provide substantial functional support for labeling discussions. As lead of Labeling sub team, draft/revise product labeling and compile supportive documentation. Ensure that each product’s labeling is in line with CCDS in a manner consistent with FDA regulations and guidelines. Support development labeling for NCEs/NBEs and labeling supplements.
• Bring Labeling sub team proposals to Leadership Committee for review and approval as required.
• Interact with Global Labeling for potential CCDS updates/proposals: With minimal assistance from senior labeling management, from a labeling perspective, advise on suitability of CCDS proposals for implementation in the US, provide impact assessment on US labeling, and function as a liaison to the Labeling sub team to facilitate US-specific labeling feedback and needs into Global Regulatory Affairs sub teams.
• Labeling Submissions to FDA - Coordinate preparation of regulatory labeling documents needed for regulatory submissions with contributing functions. Review Labeling Content deliverables for submissions for completeness, consistency and accuracy of proposed changes and supportive documentation. Provide substantial independent contribution to the supportive rationales for proposed labeling changes. Review labeling section of periodic reports such as NDA Annual Reports, PADERs, PBRERs, etc.
• In collaboration with Supervisor and upon Supervisor request, provide training to affected cross-functional colleagues, as appropriate, for labeling related procedures. Mentor Product Labeling Content staff members in labeling process and projects to build labeling expertise in collaboration with Supervisor. Serve as back-up to other Labeling sub team Chairs for other products when needed.
• Maintain and improve Regulatory Professional Knowledge: demonstrate excellent labeling regulations and guidance knowledge. Seek to improve knowledge on a continual basis to support US labeling responsibilities, processes, and management. May represent RA Product Labeling Content on working groups.
  

Requirements

• Bachelor's Degree from an accredited institution with eight to ten (8-10) years of experience in the pharmaceutical (or relevant) industry in Regulatory Affairs or scientific discipline required.
• Minimum five (5) years of labeling experience preferred in order to be able to properly understand the implications of labeling decisions throughout the business.
• Must have demonstrated strong experience drafting, editing, and reviewing product labeling and compiling supportive documentation, as well as demonstrated competence in marketed product labeling maintenance. Capable of reviewing regulatory implications of non-clinical and clinical data to evaluate the regulatory implications for product labeling with minimal support and supervision.
• Demonstrated ability to manage teams and projects with changing priorities in a dynamic environment is required; excellent proofreading/editing skills are required; excellent communication skills necessary for interacting on a daily basis to address labeling content related matters with various personnel and line management both locally and globally; high level of independence for day-to-day activities with little to no supervision; excellent judgment for independent decision making vs. upper management involvement. Ability to work in a team environment with personnel within Regulatory Affairs as well as other functions.
• Competencies critical for success of this job:
  • Excellent communication and interpersonal skills in a cross-functional team environment.
  • Excellent verbal, written and presentation skills, with strong attention to detail.
  • Demonstrated strong planning and organizational skills.
  • Thorough knowledge of regulatory and compliance requirements regarding content of labeling.
  • Ability to synthesize and present labeling content proposals in a concise manner.
  • Demonstrated agility in delivering results with fast and focused execution in a dynamic environment.
  • Continuously identify needs and develop and/or maintain local procedures to support labeling initiatives in compliance with Corporate and local regulatory requirements.
    

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