Manager Regulatory Affairs Promotional Compliance & Labeling Operations

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 Affairs Promotional Compliance and Labeling Operations role is responsible for supporting regulatory compliance review and approval of company promotional materials, leading the FDA-OPDP 2253 submissions process, and managing labeling operations-related tasks. The manager will be part of the global Medical, Legal, and 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 internationa