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Director/Sr. Director, Regulatory Labeling, Advertising and Promotion Job at Inv
Director/Sr. Director, Regulatory Labeling, Advertising and Promotion Job at InvMediabistro • North Haven, CT, United States
Director / Sr. Director, Regulatory Labeling, Advertising and Promotion Job at Inv

Director / Sr. Director, Regulatory Labeling, Advertising and Promotion Job at Inv

Mediabistro • North Haven, CT, United States
11 hours ago
Job type
  • Full-time
Job description

Senior Director, Regulatory Labeling, Advertising and Promotion

Location : New Haven, CT (Northeast preferred). This hybrid position includes both remote work and on‑site time at our HQ.

This is a strategic role leading the review, approval, and submission of advertising and promotional materials, as well as development and management of global product labeling. The Sr. Director will ensure compliance with regulatory agencies' requirements and the company’s communication objectives, monitor regulatory trends, and coordinate training. The role requires collaboration with medical affairs, legal, compliance, and commercial teams.

Responsibilities

  • Represents Regulatory Affairs as a member of the cross‑functional commercial review committee, providing regulatory input into the review and approval of promotional and non‑promotional materials
  • Maintain awareness of evolving U.S. and global regulations, codes, guidelines, enforcement actions, and policy issues affecting the pharmaceutical / biotech industry as they pertain to labeling and promotion
  • Partner and collaborate with Medical Affairs, Legal, Compliance, Commercial, and other stakeholders to ensure that promotional and non‑promotional materials are reviewed in a timely fashion throughout the product life cycle
  • Primary liaison with OPDP and effectively manage relationships with FDA contacts
  • Lead the labeling process, including CCDS, and support system updates for new or existing commercial labels
  • Provide strategic regulatory advice for labeling taking into account marketing use post‑approval
  • Interpret and communicate regulatory perspective on promotional and non‑promotional activities and risks to all stakeholders and management
  • Coordinate regulatory training on regulatory issues pertaining to advertisement and promotion activities

Requirements

  • Doctorate, master's, or bachelor’s degree in a relevant / scientific discipline (graduate degree preferred)
  • Minimum eight years working in the pharmaceutical or biotech industry with 10–15 years in Regulatory Affairs
  • Experience working with OPDP
  • Thorough knowledge of U.S. regulatory requirements for marketing authorization filings and advertising and promotion, including labeling
  • Knowledge of global drug / biologic regulations and standards, particularly promotion (EU and other international requirements)
  • Ability to work in a fast‑paced environment where drive is critical
  • Ability to assess regulatory risk and effectively communicate and coordinate discussions to influence all business functions to reach resolution
  • Strong writing, project management and communication skills
  • Ability to travel as needed (likely once per month) to our New Haven, CT office

    • At Invivyd we strive to create a welcoming and inclusive environment. All applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected characteristics.

    Invivyd is proud to be an equal‑opportunity employer. We do not accept unsolicited resumes from agencies.

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