Please note that this position can be based in San Diego, CA; Princeton, NJ; San Francisco, CA. Acadia's hybrid model requires this role to work in our office an average of 3 days per week.

Position Summary

Responsible for leading the regulatory review of advertising, promotional, and other external communications to ensure compliance with applicable regulatory requirements while supporting Acadia's commercial objectives. This role oversees the development, review, and maintenance of product labeling and provides regulatory guidance throughout the Medical, Legal, and Regulatory (MLR) review process. The position partners closely with cross-functional teams to support the timely approval and distribution of promotional and disease state materials, serves as the primary liaison with the FDA's Office of Prescription Drug Promotion (OPDP) for advertising and promotional submissions, and contributes to labeling strategies for regulatory submissions across Acadia's product portfolio.

Primary Responsibilities

• Leads the development and oversight of the processes and procedures relevant to the creation, review and approval of advertising and promotional materials as part of Acadia Medical, Legal and Regulatory review process and other external communication to ensure regulatory compliance.

• Reviews external communications materials, sales and marketing materials, including training, for compliance to current regulations and guidance.

• Represents the regulatory department with senior management on regulatory strategy and risk analysis as it relates to Acadia’s commercial strategy and compliance.

• Participates in training for sales and marketing on advertising and promotional material.

• Represents the company to outside customers and agencies and makes presentations as needed on current regulatory issues pertaining to advertising and promotional activities.

• Other responsibilities as assigned

Education/Experience/Skills

• Bachelor’s degree in a scientific discipline or related field. MBA preferred.  Targeting 10 years progressively responsible Regulatory Affairs experience with a focus on advertising and promotional regulations.  An equivalent combination of relevant education and experience may be considered.

• Experience communicating and negotiating directly with OPDP and performing risk assessment.

• Significant demonstrated experience developing and executing complex and innovative global regulatory strategies, assessing & communicating risk/benefit to senior management, and influencing organizational direction as it pertains to compliance advertising and promotion materials.

• Experience with labeling development and life-cycle management

• Experience involving complex negotiations with regulatory authorities.

• Experience in organizational management, including matrix management of senior professionals and higher-level project teams.

• Thorough knowledge of US and international regulations, as they apply to pharmaceutical drug development.

• Demonstrated problem solving abilities and conflict resolution skills.

• Excellent verbal and written organizational and communication skills; Experience influencing and communicating policy issues.

• Excellent collaboration skills with 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 willing and able to travel both domestically and internationally.

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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