Director, Regulatory Affairs

Role Summary:

Fore Biotherapeutics is a next-generation precision oncology company focused on the development of Plixorafenib, an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. The Director, Regulatory Affairs will be responsible for supporting the development and implementation of global regulatory strategy, serve as the regulatory lead on clinical study teams, and develop submission plans for all regulatory files related to clinical trial and marketing applications. This individual will support the cross-functional team and provide direction on the interpretation and application of global regulations and guidance's related to clinical trials.

Essential Duties and Responsibilities:

• Applies in-depth knowledge of the company, external environment, and industry best practices to analyze/solve issues and to provide regulatory guidance to cross-functional colleagues.
• Leads the planning, preparation, writing, and review of Clinical Trial Applications and IND amendments, in collaboration with cross-functional team members and external vendors, as needed.
• Leads the planning, preparation, writing, and review for Ex-US health authority interactions in collaboration with the cross-functional team and external vendors (as needed). Attends formal meetings with the Health Authorities.
• Leads the preparation and writing of responses to health authority comments and questions pertaining to clinical trial matters in collaboration with the cross-functional team and external vendors (as needed).
• Ensures compliance with regulatory agency requirements. Coordinates resolution of submission issues interdepartmentally to ensure compliance to document management standards.
• Additional duties may include support for US health authority interactions, training colleagues on e-submission procedures and software for electronic submissions.
• Applies in-depth knowledge to identify and assess areas of regulatory risks and maintain internal trackers and dashboards.
• Ensures team awareness of evolving global regulations, guidelines, and health authority expectations.
• Support QA in developing and reviewing SOPs and preparing and hosting regulatory inspections.
• Works within the department and with other functional areas on process development and improvements.
• Provides overall organizational support as company grows its product development pipeline
• 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 10 years' experience in regulatory affairs with a focus on clinical documentation and life-cycle management; experience with small molecules and orphan drugs preferred
• Oncology experience required
• Demonstrated experience in NDA submissions and best practices
• Experience in preparation and submission of documents in eCTD format; a working knowledge of FDA and EMA 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 regulatory documents. E.g., briefing books, investigator brochures, protocols, clinical study reports, clinical summaries.
• Experience in eCTD format, structure, and lifecycle management.
• Knowledge of both GCP and GMP regulations
• High attention to detail and accuracy, with strong project management abilitie
• Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.

Fore Biotherapeutics is an Equal Opportunity Employer. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.