Associate Director Regulatory Affairs CMC

Summary

Join Acadia Pharmaceuticals as an Associate Director, Regulatory CMC, and contribute to the development and implementation of global regulatory CMC strategies for investigational and marketed small molecule therapeutics. Coordinate global CMC regulatory activities for clinical trials and marketing approvals, and support the product lifecycle. Represent the regulatory function on multi-disciplinary teams and interact with global regulatory agencies. Serve as a resource for CMC team members regarding regulatory requirements. This role requires a Bachelor’s degree in a life science field and at least 8 years of experience in CMC Regulatory Affairs, with a focus on small molecule drug development. The position offers a competitive base salary, discretionary bonus, and equity awards.

Requirements

• Bachelor’s degree in a life science or related field
• Targeting at least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development
• An equivalent combination of relevant education and applicable job experience may be considered
• Knowledge and understanding of global regulatory CMC requirements and guidelines
• Previous experience in the preparation and submission of the CMC components of IND/CTA and NDA and ex-US MAA submissions
• Ability to work in a cross-functional team environment and manage competing priorities
• Strong interpersonal skill, attention to detail and excellent organizational, computer, and documentation. 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/influencing business partners and departmental leaders regarding matters of significance to the department or segments of the organization
• Adept at communicating a clear vision among team members effectively aligning resources to achieve functional area goals

Responsibilities

• Supports 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
• Organizes and contributes to the timely preparation of high quality CMC sections of INDs/CTAs, NDAs, MAAs and amendments for submission to global regulatory authorities, supporting the conduct of clinical trials and marketing applications
• Contributes as a key regulatory representative with external parties for CMC development activities
• Interacts with regulatory agencies for CMC development activities as required
• 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 determine applicability to company activities
• Other duties as assigned

Benefits

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