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Acadia Pharmaceuticals Inc. · 1 day ago

Associate Director, Regulatory Affairs CMC

San Diego, CA

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$160K/yr - $200K/yr

8+ years exp

Acadia Pharmaceuticals is committed to making a difference for underserved neurological and rare disease communities. The Associate Director, Regulatory CMC, will contribute to the development and implementation of global regulatory CMC strategies, coordinate regulatory activities for clinical trials, and interact with global regulatory agencies.

BiotechnologyHealth CarePharmaceutical

Hiring Manager

Ben Grieser

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

Qualification

CMC Regulatory AffairsIND/CTANDA submissionsGlobal regulatory requirementsCross-functional teamworkAttention to detailMeet deadlinesInterpersonal skillsOrganizational skillsFlexibilityNegotiation skillsEffective communication

Required

Bachelor's degree in a life science or related field

At least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development

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