Director of Regulatory Affairs

3 weeks ago

Princeton, United States BioPhase Full time

Hybrid - 3 days a week in office - Princeton, NJ

The Associate Director of Regulatory Affairs Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions with Labeling Management Team and Executive Labeling Committee as appropriate, and participating in label-related Health Authority negotiations.

Primary Responsibilities

  • Support with developing draft labeling text (e.g. USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and labeling update of approved package inserts to support product lifecycle management
  • Support implementation of a labeling review and approval process, including documentation of label history, LMT/ELC decisions, and exceptions from CCDS to facilitate end to end global labeling process
  • Ensure labeling strategy is aligned with overall regulatory and program strategy by working collaboratively with key internal stakeholders, including but not limited to Regulatory Affairs, Clinical Research, Drug Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, and Supply Chain
  • Assist or otherwise lead and facilitate cross-functional labeling and related forums and meetings, such as LMT to support draft Label development
  • Interact with Regulatory Strategy Lead to ensure timely submission and implementation of global labeling requirements that are consistent with the companys position in the CCDS and in compliance with local labeling requirements
  • Effectively communicate the regulatory labeling strategy, risks, mitigations and overall plans
  • Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities
  • Drive the development, implementation and maintenance of policies and procedures for the creation and management of labeling and communicate to appropriate stake holders
  • Manage the review, QC and approval process for all product labeling components and CCDS
  • Support the development of labeling negotiations strategic plans. Manage the internal process for review and resolution of health-authority feedback on draft labeling. Participate in label-related Health Authority negotiation meetings
  • Train and mentor other RA Labeling colleagues or cross-functional team members in various matters relating to RA labeling

Education and Experience

  • Bachelor degree in a scientific discipline or related field; advanced degree preferred.
  • Targeting 8 years of progressively responsible Regulatory Affairs experience and 6 years experience in global labeling. This includes a thorough understanding of global regulatory labeling requirements and strategic labeling planning.
  • Must have significant experience in global prescription drug labeling, U.S., EU, Australia, Canada, Japan, and/or Switzerland
  • Must have a strong track record of leading labeling content development through regulatory submission and review process, Health Authority negotiations resulting in product approval
  • Demonstrated experience in developing and executing complex and innovative global labeling strategies, assessing & communicating risk/benefit to senior management, and influencing organizational direction as it pertains to labeling negotiations with regulatory authorities.

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