Associate Director, Regulatory Affairs (CMC)

Role Summary:

Fore Biotherapeutics is seeking an experienced and highly motivated regulatory professional to support the development of plixorafenib, an investigational, orally available, small molecule selective inhibitor of mutated BRAF. The Associate Director, Regulatory Affairs will be responsible for supporting the development and implementation of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and managing the preparation of supporting documents. This individual will support the CMC Team and provide direction on the interpretation and application of global CMC regulations and guidances related to cGMP and will act as the key interface between CMC SMEs, Regulatory Affairs, and the Development team.

Essential Duties and Responsibilities:

• Attend study team, project team, and CMC strategy meetings to provide CMC-related regulatory guidance to cross-functional colleagues.
• Manage the planning, preparation, writing, and review of CMC documentation for Clinical Trial Applications, IND/IMPD submissions and amendments, marketing applications, and other communications with health authorities.
• Manage the planning, preparation, writing, and review for CMC-related health authority interactions in collaboration with the CMC team and external vendors (as needed). Attend formal CMC-related meetings with the Health Authorities.
• Manage the preparation and writing of responses to health authority comments and questions pertaining to CMC matters in collaboration with the CMC team and external vendors, as needed.
• Ensures compliance with regulatory agency requirements. Coordinates resolution of submission issues interdepartmentally to ensure compliance and to document management standards.
• Additional duties may include training colleagues on e-submission procedures and software producing electronic submissions.
• Identify and assess areas of CMC-related regulatory risks and maintain internal trackers and dashboards.
• Ensure team awareness of evolving global regulations, guidelines, and health authority expectations.
• Support QA in developing and reviewing SOPs, and preparing and hosting regulatory inspections.
• Work within the department and with other functional areas on process development and improvements to and provide overall organizational support as the company grows
• Travel up to 10% time, based upon program needs.

Education and/or Work Experience Requirements:

• Bachelor's degree in a scientific discipline is required; advanced degree preferred.
• Minimum 8 years of experience in regulatory affairs with a focus on CMC documentation and life-cycle management; experience with small molecules and orphan drugs preferred.
• Experience in preparation and submission of CMC modules in eCTD format; a working knowledge of FDA and EMA CMC guidance documents and regulations is required.
• Ability to influence and negotiate professionally at various levels within cross-functional teams and with external partners, while maintaining positive working relationships.
• Ability to work both independently with minimal direction and within project teams, committees, corporate partners, etc., to attain group goals.
• Ability to write, edit, and/or collaborate on the development of high-quality CMC-regulatory documents, eg, briefing books, IMPDs, Module 3 documents.
• Experience in eCTD format, structure, and lifecycle management.
• Knowledge of both GCP and GMP regulations.
• High attention to detail and accuracy, strong project management abilities.
• Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Fore Bio provides equal employment opportunities (EEO) to all employees and applicant for employment without regard to religion, race, creed, color, sex orientation, national origin, age, marital status or any other characteristic protected by applicable federal, state, or local law.