Associate Director, Regulatory Affairs ROW

Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office an average of 3 days per week.

Position Summary

The Associate Director, Regulatory Affairs ROW is responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and marketing of Acadia products, including the regulatory compliance for advertising and promotion of marketed products. This role will also support the Regulatory Affairs team in the compilation of regulatory documentation to support ex-US/EU regulatory development and marketing application submissions in compliance with corresponding regulations. In addition, this role will support addressing regulatory needs for regional access and commercialization efforts.

Primary Responsibilities

• Provides regulatory strategic direction and support for assigned global development programs/development program activities and assists Sr. Regulatory Affairs staff with their development program activities and deliverables.
• Designs and implements regulatory strategies with Sr. Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management.
• Provides regulatory strategic direction to support early access programs in compliance with local laws and regulations.
• Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with global regulatory authorities outside of US and EU geographies.
• Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities intended to further the development of ACADIA development programs.
• With limited oversight, interacts effectively with cross functional project team members in order to communicate regulatory objectives/strategies for regulatory deliverables, including ensure timely, high-quality and content appropriateness of documentation supporting regulatory submissions, ensuring departmental timelines are achieved.
• Supports Sr. Regulatory AdPromo staff by assisting in the review of advertising and promotional pieces for completeness and compliance with established requirements, including but not limited to external communications materials, sales and marketing, training and product promotional strategies.
• Support Sr. Regulatory AdPromo staff by assisting in the review of communications related to early access programs to ensure compliance with local laws and regulations.
• Participates in Medical Review Committee to review medical information documents for completeness and compliance with established company requirements.
• Helps in establishment and execution of operational objectives of assigned and Sr. Staff projects.
• Assists in the preparation and maintenance of appropriate reports and other documents required to support or maintain regulatory development and marketing applications.
• Assists in the cataloging and maintenance of regulatory application submissions and correspondence.
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
• Reviews SOPs pertaining to Regulatory Affairs.
• Keeps abreast of regulatory procedures and changes.
• Other responsibilities as assigned.

Education/Experience/Skills

• PharmD, PhD, MD degree in a life science or healthcare or related field. Targeting 8 years of progressively responsible experience in the pharmaceutical or related industry; regulatory drug development experience is required. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
• Ability to understand and explain detailed regulatory affairs and compliance programs and/or issues.
• Ability to effectively present information to senior regulatory management, other departments or external groups.
• Ability to comply with changing regulatory procedures.
• Ability to adapt to changing priorities and prioritize work effectively.
• Strong Project Management capabilities.
• Excellent Microsoft Office skills.
• Must be able and willing 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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