Director, Global Regulatory CMC — Small Molecule Lead

Acadia Pharmaceuticals; San Diego (CA); Hybrid; USD 190,000 - 237,000; Full time

Benefits offered by this job

Competitive base salary

Medical, dental, and vision insurance

401(k) Plan with company match

Employee Stock Purchase Plan

Vacation days (15+)

Paid holidays (13-15)

Paid sick time (10)

Parental leave

Tuition assistance

Job summary

Acadia Pharmaceuticals seeks a Director, Regulatory CMC to lead global regulatory strategies for small molecules, from development through commercialization. You will guide IND/CTA filings, NDA/MAA submissions, and lifecycle management, coordinating with R&D, Manufacturing, Quality, and Regulatory teams.

This leadership role requires a decade in CMC regulatory affairs with oversight experience, cross-functional collaboration, and travel.

Qualifications

• Bachelor’s degree in life science or related field; equivalent experience may be considered.
• 10+ years in CMC regulatory affairs with 5+ years in management.
• Knowledge of global CMC requirements and guidelines.
• Experience preparing CMC sections of INDs/CTAs; NDA/MAA submissions.
• Ability to lead cross-functional teams and manage competing priorities.
• Strong interpersonal skills, organization, and deadline focus.
• Willingness to travel domestically and internationally.

Responsibilities

• Lead global regulatory CMC strategies for development to commercialization.
• Coordinate with R&D, Manufacturing, Quality, and Regulatory to implement strategy.
• Prepare high-quality CMC sections for INDs, CTAs, NDAs, and MAAs.
• Represent CMC regulatory on cross-functional teams and with agencies.
• Provide CMC regulatory guidance and risk mitigation within development teams.
• Ensure compliance with applicable regulatory requirements for CMC activities.
• Evaluate manufacturing changes and assess regulatory implications.
• Stay updated on relevant guidelines and determine applicability.
• Perform additional duties as assigned.

Skills

CMC regulatory affairs

Regulatory strategy

Cross-functional collaboration

Negotiation

Travel flexibility

Project leadership

Attention to detail

Education

Bachelor’s degree in life science

Job description

Acadia Pharmaceuticals seeks a Director, Regulatory CMC to lead global regulatory strategies for small molecules, from development through commercialization. You will guide IND/CTA filings, NDA/MAA submissions, and lifecycle management, coordinating with R&D, Manufacturing, Quality, and Regulatory teams.

This leadership role requires a decade in CMC regulatory affairs with oversight experience, cross-functional collaboration, and travel.