Title: Director Regulatory Affairs Advertising & Promotion
Location: San Diego United States
Job Description:
Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
Position Summary
Responsible for directing the regulatory aspects of internal and external communications including advertising and promotional activities as well as facilitation of labeling development, maintenance and distribution for all Acadia products. Coordinates the development and implementation of regulatory strategies for promotion and advertising plans and is a leader in the Medical, Legal and Regulatory Review process to support approval and dissemination of marketed product and disease state promotional material. Liaises with FDAs Office of Prescription Drug Promotion (OPDP) for Advertising and Promotion submissions and works with development teams as concerns the construct of proposed labeling for regulatory submissions according to product data and Acadia objectives.
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.
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.
Key Skills:
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 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.
Scope
Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives. Establishes strategic plans for designated function(s). Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives. Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long term success of the Company.
Physical Requirements
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.
LI-HYBRID
