Director Regulatory Affairs Labeling

Position Summary

The Director of Regulatory Affairs (RA) Labeling will lead 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 (LMT) and Executive Labeling Committee (ELC), and participating in label-related Health Authority negotiations. The Director will be responsible for the end-to-end labeling process including lifecycle management of labeling and artwork for all Acadia products both in development and on market. This will include management of internal global Company Core Data Sheet (CCDS) process, labeling SOP, initial draft label development, managing label review and finalization process, and managing post-approval labeling updates.

Primary Responsibilities

• Guide, develop and author 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
• Define and implement a labelling 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
• Oversee or otherwise lead and facilitate cross-functional labeling and related forums and meetings, such as LMT and ELC 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 company's 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
• Oversees and/or manage the review, QC and approval process for all product labeling components and CCDS
• Responsible for 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
• Other duties as assigned

Education and Experience

• Bachelor's degree in a scientific discipline or related field; advanced degree (e.g., PharmD) preferred. Targeting 10 years of progressively responsible Regulatory Affairs experience and 8 years' experience in global labeling. This includes thoroughly understanding global regulatory labeling requirements and strategic labeling planning. Must have significant experience in global prescription drug labeling, U.S., EU, Australia, Canada, Japan, and Switzerland. An equivalent combination of relevant education and applicable job experience may be considered.
• Must have a strong track record of leading labeling content development through the 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.
• Thorough knowledge of US and international regulations as they apply to pharmaceutical drug development.
• Strong writing skills; able to process scientific data and effectively summarize into the appropriate detail for labeling content.
• Experience in organizational management, including matrix management of senior professionals and higher- level project teams.
• Ability to work in a cross-functional team environment and a flexible team-oriented perspective.
• Demonstrated problem solving abilities and conflict resolution skills.
• Excellent verbal and written organizational and communication skills.
• Excellent transverse collaboration skills, demonstrated ability to work effectively in cross-functional and/or global teams.
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.
• Must be able to travel on occasion.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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