Director Regulatory Affairs Advertising & Promotion

Acadia Pharmaceuticals; San Diego (CA); Hybrid; USD 179,000 - 224,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs leader to direct communications and compliance for advertising and promotional activities. This role requires a strong understanding of regulatory strategies and the ability to liaise with the FDA. The ideal candidate will have extensive experience in regulatory affairs, particularly in advertising regulations, and will play a crucial role in ensuring compliance across all promotional materials. Join a forward-thinking company that is making significant advancements in neuroscience and healthcare, and contribute to impactful projects that improve lives.

Benefits

Discretionary bonus

Equity awards

Competitive base salary

Qualifications

• 10 years of Regulatory Affairs experience focusing on advertising regulations.
• Experience communicating with OPDP and developing regulatory strategies.

Responsibilities

• Direct regulatory aspects of advertising and promotional activities.
• Lead development and oversight of compliance materials.

Skills

Regulatory Affairs

Communication Skills

Negotiation Skills

Risk Assessment

Labeling Development

Problem Solving

Organizational Management

Cross-Functional Collaboration

Education

Bachelor's degree in a scientific discipline

MBA

Job description

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit us at Acadia.com and follow us on LinkedIn and X.

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 FDA's 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.

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.

Compensation and Benefits

In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location. Salary Range: $179,000 — $223,300 USD.

EEO Statement (US-Based Employees): 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 [e-mail] 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.

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Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.