Director, Global CMC Regulatory Affairs

Acadia Pharmaceuticals; Princeton (NJ); Hybrid; USD 190,000 - 237,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) match

Employee Stock Purchase Plan

Paid vacation and holidays

Paid sick time

Parental leave

Tuition assistance

Job summary

Acadia Pharmaceuticals seeks a Director, Regulatory CMC to lead global regulatory CMC strategies from development through commercialization. You will guide cross-functional teams, interact with regulatory authorities, and shape development and lifecycle plans for worldwide programs.

This role focuses on small molecule therapies and requires extensive regulatory submission experience. The position involves travel and a hybrid work model, with office days in Princeton, NJ, or other US locations as

Qualifications

• Bachelor’s degree in life science or related field. An equivalent combination of education and experience may be considered
• Targeting 10 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development, with 5 years in a management role
• Knowledge and understanding of global regulatory CMC requirements and guidelines
• Previous experience in the preparation and submission of the CMC components of IND/CTA filings as well as regulatory authority meeting Briefing Packages and NDA and ex-US MAA submissions
• Ability to work in a cross-functional team environment and manage competing priorities
• Strong interpersonal skills, attention to detail and excellent organizational skills
• Ability to meet deadlines and perform multiple tasks in a fast-paced setting
• Demonstrated personal initiative, responsibility, flexibility, the ability to work under limited supervision, and ability to handle multiple project assignments
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or segments of the organization
• Self-directed and resourceful, with the ability to anticipate needs, identify opportunities, and drive work forward independently
• Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals
• Willingness and ability to travel domestically and internationally as needed

Responsibilities

• Manages the CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements
• Coordinates with R&D, Pharmaceutical Development, Manufacturing, Quality and Regulatory colleagues and other functional areas to develop and implement CMC regulatory strategy
• Manages the timely preparation of high quality CMC sections of INDs, CTAs, NDAs, MAAs and amendments for submission to regulatory authorities supporting the conduct of clinical trials and marketing applications worldwide
• Contributes as a key regulatory representative with external parties and acts as a point of contact with regulatory agencies for CMC development, product registration, and life-cycle activities
• Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks
• Participates in ensuring compliance of CMC activities with applicable regulatory requirements
• Evaluates Manufacturing processes and changes, assesses the regulatory implications and supports their implementation
• Maintains current knowledge of the relevant guidelines and regulations and determines applicability to company activities
• Other duties as assigned

Skills

CMC Regulatory Affairs

Regulatory strategy

Cross-functional teamwork

Regulatory submissions

Project leadership

Education

Bachelor's in life science

Job description

Acadia Pharmaceuticals seeks a Director, Regulatory CMC to lead global regulatory CMC strategies from development through commercialization. You will guide cross-functional teams, interact with regulatory authorities, and shape development and lifecycle plans for worldwide programs.

This role focuses on small molecule therapies and requires extensive regulatory submission experience. The position involves travel and a hybrid work model, with office days in Princeton, NJ, or other US locations as