May 31st, 2022 Regulatory Affairs

Director Regulatory Affairs Advertising and Promotion

Princeton, New Jersey, United States

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Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.

Position Summary:

The Regulatory Affairs Advertising and Promotion Director is responsible for reviewing internal and external communications including advertising and promotional activities as well as facilitation of labeling development, maintenance and distribution for all Acadia products! This role coordinates the development and implementation of regulatory strategies for promotion and advertising plans and provides Regulatory leadership and mentorship in the Medical, Legal, and Regulatory Review process to support approval and dissemination of marketed products and disease state promotional material.

This role will work closely with the Head for Regulatory Advertising and Promotion and other Sr. Regulatory Affairs Dept. Staff with the development and implementation of regulatory strategies for promotion and advertising plans, and projects concerning the construct of proposed labeling for regulatory submissions according to product data and Acadia objectives.

Primary Duties & Responsibilities:

  • Reviews promotional/non-promotional materials, including training, for completeness and compliance with FDA regulations, guidance documents, and company policy
  • Represents the regulatory perspective at and being responsible for the Medical, Legal, and Regulatory Review process to support review and approval of appropriate materials
  • Assumes a leadership role in advising teams on the regulatory impact of new promotional messages or concepts, updates to label, and provides regulatory guidance on corporate communications, medical affairs activities, and appropriate pre-approval activities with some managerial oversight
  • Participates in training of marketing and sales team on Ad Promo and Labeling and Update and advise them on changes in regulations, policies, and execution which may impact the Acadia’s promotional activities
  • Leads all aspects of the FDA-OPDP 2253 submission process for all Acadia products

Education/Experience/Skills:

  • Science or healthcare-related degree preferred, including BS, MS, MPH, PharmD.
  • Desired 8 years of experience in the pharmaceutical or related industry; a minimum of 4 years experience with regulatory review of advertising and promotional materials for prescription drug and/or biologic products.
  • Experience communicating and negotiating with different levels within the organization and performing risk assessment
  • Demonstrated experience developing, carrying out, and influencing interpersonal direction as it pertains to compliant advertising and promotion materials or activities
  • Experience in interpersonal management, including matrix management of senior professionals and higher-level project teams
  • Ability to interpret and implement FDA regulations as it pertains to Advertising and Promotion of Pharmaceutical products.
  • Ability to problem tackle and efficiently handle or resolve conflicts.
  • Excellent verbal and written interpersonal and communication skills, and experience influencing and communicating Regulatory Advertising and Promotional issues
  • Ability to negotiate with business partners or management regarding Regulatory Ad Promo matters of significance to the organization.
  • Ability to efficiently present information to senior regulatory management, other departments or external groups.
  • Ability to adapt to changing priorities and prioritize work efficiently.

Scope:

Provides proactive mentorship to cross-functional team members based on technical and regulatory knowledge towards the development of Regulatory Advertising and Promotion materials and strategies! This person will identify, assess, and efficiently handle regulatory risks associated with advertising and promotional materials or activities for assigned products. Works on complex issues where analysis of situations or data requires an in-depth knowledge of the functional area and related interpersonal objectives. Reliably participates in key meetings to provide Regulatory Advertising and Promotion guidance to help support Acadia’s business objectives.

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. The employee must occasionally lift and/or move up to 15 pounds.

#LI-Hybrid #LI-MH1

What we offer you:

  • Competitive base, bonus, new hire and ongoing equity packages
  • Medical, dental, and vision insurance
  • 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
  • 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
  • 10 days of paid sick time
  • Paid parental leave
  • Tuition assistance

EEO Statement:

Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.