Associate Director/Director Regulatory
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 submissions, Annual Reports, Investigator Brochures, IND amendments, briefing book for FDA meetings, as well as responses to requests.
Duties and Responsibilities
- Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs
- Provide regulatory leadership and guidance to project teams
- Develop response strategies and submissions to regulators
- Develop briefing packages for meetings with FDA and other health authorities
- Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through commercial)
- Integrate regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
- 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
- Identify and assess regulatory risks for assigned projects or programs
- Prepare and deliver effective presentations for external and internal audiences
- Contact regulatory agencies relevant to assigned projects or programs, as appropriate
- Participate and contribute in Health Authority meetings as required
Qualification and Requirements
- MS degree in life/health/technical sciences preferred
- Minimum 8+ years’ regulatory experience within the biotech or pharmaceutical industry within the drug development and approval process in INDs/NDAs
- 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 attain group goals
- Demonstrate excellent communication skills
- Ability to represent the group 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.
- Regulatory experience: 8 years (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.
Interested candidates should submit their resume.