Regulatory Affairs Director

Description:

Acadia Pharmaceuticals Inc. is seeking an experienced Director, Regulatory Affairs Labeling to lead global labeling strategy and lifecycle management across the company’s pharmaceutical product portfolio. This full-time hybrid role may be based in San Diego, South San Francisco, or Princeton, NJ, with a requirement of three days per week on-site.

The Director will oversee the entire labeling process, from initial development and regulatory submission through to post-approval updates. The role requires expert-level understanding of global regulatory labeling requirements and deep cross-functional collaboration across Regulatory, Clinical, Medical, Legal, Supply Chain, and other functions. This individual will also participate in Health Authority negotiations and ensure Acadia’s labeling processes align with international standards and company goals.

Key Responsibilities:

• Lead and author key labeling documentation (e.g., USPI, PPI, Med Guide, EU SmPC, EUPIL) for new product submissions and updates

• Drive the development and implementation of labeling review processes and global Company Core Data Sheets (CCDS)

• Facilitate labeling-related meetings including Labeling Management Team (LMT) and Executive Labeling Committee (ELC)

• Coordinate strategic labeling activities across regions to ensure consistency and compliance with local and global regulatory expectations

• Lead internal labeling SOP development and training

• Serve as primary labeling liaison for Health Authority negotiations and submissions

• Maintain current knowledge of evolving global labeling regulations (FDA, EMA, etc.)

• Mentor junior Regulatory Affairs Labeling staff and contribute to team growth

• Collaborate with cross-functional stakeholders to manage labeling risks and resolve challenges proactively

Required Skills & Knowledge:

• Strong scientific acumen and ability to synthesize complex data into compliant labeling content

• In-depth regulatory expertise across US, EU, and other major global markets

• Excellent written and verbal communication skills, including stakeholder influence and negotiation

• Strong organizational and project management capabilities in matrix environments

• Proficiency in regulatory documentation systems and labeling workflows

Educational Requirements:

• Bachelor's degree in a scientific discipline required; PharmD or advanced degree preferred

• Equivalent combination of education and experience may be considered

Physical Requirements:

• Standard office work environment with some lifting (up to 20 lbs) and occasional travel

• Must be able to work from designated offices three days per week as part of Acadia’s hybrid model

Benefits and Compensation:

• Competitive base salary plus discretionary bonuses and equity awards

• Comprehensive health benefits (medical, dental, vision)

• Generous PTO and paid holidays

• Opportunities for career growth in a purpose-driven, innovative organization