Director, Regulatory Affairs CMC

Please note that this position can be based in San Diego CA San Francisco CAOR Princeton NJ. Acadiashybrid modelrequires this role to work in our office three days per week on average.

Position Summary

Join Acadia as the Director Regulatory CMC and play a critical role in advancing innovative small molecule therapies from development through commercialization this leadership position you will develop and execute global regulatory CMC strategies that support clinical development marketing approvals and lifecycle management across key regions including GCC LATAM and APAC. You will serve as the regulatory CMC expert on cross-functional teams guide global regulatory interactions and help shape successful development and commercialization strategies for our product portfolio. This is an opportunity to make a meaningful impact on programs that bring important therapies to patients around the world.

Primary 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

Education/Experience/Skills

• Bachelors degree in life science or a 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

Physical Requirements

This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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