The Director, Regulatory Affairs will contribute to the formulation of regulatory strategy, serve as the regulatory lead on relevant project teams, and act as the regulatory contact as required. This individual will oversee the planning and execution of major submissions and responses to regulatory authorities related to IND/NDA and IMPD/MAA submissions, Annual Reports, Investigator Brochures, IND amendments, and briefing packages for regulatory meetings. The position will report to the Senior VP Development.
Duties and Responsibilities
- Responsible for coordinating all aspects of US and ex-US regulatory submissions relevant to assigned projects or programs
- Prepare, manage, and maintain regulatory submissions (e.g., INDs, IMPDs, CTAs, amendments, safety reports, DSUR/annual reports, meeting packages, etc.) in accordance with applicable regulations and with the support of appropriate functions
- Actively contribute to the development and implementation of regulatory strategy for assigned projects and programs in all stages of development (IND through commercial)
- Coordinate efforts with external publishing vendor for building submissions in the CTD format
- Provide regulatory leadership and guidance to project teams
- Develop a strategy for NDA submissions
- Manage or delegate the management of the completion of documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes
- Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities
- Provide regulatory advice related to medical affairs and commercial strategy and activities pre- and post-launch
- Serve as regulatory member of material review committee for field-based medical affairs and commercial materials
- Identify and assess regulatory risks for assigned projects or programs and develop mitigation strategies
- Prepare and deliver effective presentations for external and internal audiences
- Contact regulatory agencies relevant to assigned projects or programs and coordinate meetings throughout the process of seeking regulatory advice
- Participate and contribute in Health Authority meetings as required
- Review proposed specification changes for compliance with current regulatory filings
Qualification and Requirements
- BS, BA or MS in life/health/technical sciences required. PhD or PharmD in life/health/technical sciences preferred.
- Minimum 8+ years’ regulatory experience within the biotech or pharmaceutical industry including the drug development and approval process in INDs/NDAs and IMPDs/MAAs
- Managerial/group leader experience preferred
- Strong experience in the full range of pre- and post-launch regulatory activities preferred
- Review commercial marketing materials to ensure compliance with regulatory requirements.
- Broad experience with clinical, CMC and preclinical regulatory activities related to US and ex-US requirements
- Proven experience navigating successful submissions is required
- Preferences include recent successful NDA experience
- Knowledge and understanding of global regulatory requirements
- Ability to work both independently with minimal direction and within project teams, committees, corporate partners, etc. to achieve regulatory goals
- Strong familiarity with regulatory guidance from FDA, ICH and other authorities
- Demonstrate excellent communication skills
- Ability to represent Regulatory Affairs in project teams
- Demonstrate strong organizational skills, including the ability to prioritize tasks
- Experience in interfacing with relevant regulatory authorities
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
- Experience in interpretation and application of regulations, guidelines, policy statements, etc.
- Extensive experience with development, review, formatting, finalizing and electronic publishing of regulatory documents in CTD format
- Regulatory: 8 years (Required)
- Managerial experience preferred
- Some travel required
- Calithera Biosciences, Inc.is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
Interested candidates should submit their resume to firstname.lastname@example.org