Manager Regulatory Affairs Promotional Compliance & Labeling Operations
Job Description
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate life. For 30 years 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 FDA-approved drug 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 neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X.
Position Summary
The Manager, Regulatory Promotional Compliance and Labeling Operations role is responsible for supporting regulatory compliance review and approval of company promotional materials, leading FDA-OPDP 2253 submissions process, and managing labeling operations related tasks. The manager will be part of the global Medical, Legal, Regulatory (MLR) process, and accountable for ensuring all required revisions by MLR reviewers were implemented before approving promotional materials for dissemination or submission to Health Authorities as required. They will also support the end-to-end global labeling process by performing quality reviews of draft labels for all Acadia products both in development and on the market to ensure compliance with Health Authorities labeling requirements.
Primary Responsibilities
- Reviews all US, Canada, and EU promotional/non-promotional materials, including sales training and global promotional templates, to ensure required revisions by MLR reviewers were implemented before approving promotional materials for external dissemination or submission to health authorities as required.
- Collaborate with Marketing, Marketing Operations, and Regulatory Operations to ensure timely submission of all US promotional materials to FDA-OPDP prior to the first use date.
- Ensures compliance with the FDA-OPDP 2253 submission process for all ACADIA marketed products.
- Support MLR process optimization efforts to ensure compliance with Global Health Authorities requirements for submission of promotional materials as required.
- Support with formatting and QC of draft labeling text (e.g. USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and labeling update of approved package inserts to support product lifecycle management.
- Support implementation of labeling review and approval process, including documentation of label history, LMT/ELC decisions, and exceptions from CCDS to facilitate end to end global labeling process.
- Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities.
- Support the development of annotated labels post approval and archiving labeling correspondence from Health Authorities.
- Other duties as required.
Education and Experience
Bachelor's degree in a scientific discipline or related field. Targeting 5 years of Regulatory Affairs experience. Must have a strong understanding of FDA Regulatory Advertising and Promotion regulations, FDA-OPDP 2253 submission process, and global regulatory labeling requirements. An equivalent combination of relevant education and experience may be considered.
Key Skills:
- Ability to interpret and implement Regulatory Health Authorities requirements as it pertains to labeling, and Advertising and Promotion of Pharmaceutical products.
- Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
- Self-organized, self-directing, and highly motivated.
- Strong critical thinking, problem solving abilities, and analytical skills.
- Knowledge of US and international regulations as they apply to Regulatory Affairs.
- Strong writing skills; able to process scientific data and effectively summarize into the appropriate detail for labeling content.
- Ability to work in a cross-functional team environment and a flexible team-oriented perspective.
- Good verbal and written organizational and communication skills.
- Skilled at negotiating with business partners or management regarding matters of significance to the organization.
- Ability to adapt to changing priorities and prioritize work effectively.
- Ability to travel.
Scope
Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors and an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.
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-RT1 #LI-hybrid
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.
What we offer you (US-Based Employees):
- 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 (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 talentacquisition@acadia-pharm.com 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.
Notice for California Applicants: Please see our California Applicant Privacy Notice within our Privacy Policy.
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 the 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.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity
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