Director, Regulatory Affairs Advertising & Promotion

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.

What we offer US-based Employees:
Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
Employer-paid life, disability, business travel and EAP coverage
401(k) Plan with a fully vested company match 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
13 -15 paid holidays, including office closure between December 24th and January 1st
10 days of paid sick time
Paid parental leave benefit
Tuition assistance