G1 Therapeutics is currently recruiting a Sr. Director, Regulatory Affairs to join our team, reporting to the VP of Global Regulatory Affairs. In this role you will be responsible for providing regulatory leadership in support of the development programs at G1 Therapeutics. This includes the development and implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. This person represents the regulatory function on cross functional teams and serves as a resource to team members for the regulatory requirements to conduct drug development activities.
NOTE: This position is currently remote based, with flexibility to remain so at a future date.
Develop and implement regulatory product strategies
Represent the regulatory function on cross-functional development teams
Provide regulatory guidance and strategy including identifying and assessing regulatory opportunities, risks, mitigations, and contingencies
Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, NDA, MAA) throughout the lifecycle of assigned projects
Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; be primary liaison with regulatory authorities for day-to-day interactions
Lead and oversee regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
Ensure that regulatory documents are accurate, complete and verifiable and confirm compliance with regulatory requirements
Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
Provide interpretation of and advice regarding regulations, directives, and guidance
Coordinate and prepare responses to requests for information from regulatory authorities
Train, manage, and mentor other regulatory affairs personnel
Work externally to engage in regulatory policy initiatives
Other duties as assigned
Bachelor’s degree in a scientific discipline; or advance degree highly desired
Relevant experience within oncology therapeutics required
12+ years regulatory industry experience in biopharmaceuticals
Knowledge and understanding of global regulations and guidelines
Previous experience in the preparation and submission of regulatory documents
Previous experience in attending and leading a team to prepare and conduct health authority meetings (e.g. FDA pre-IND, pre-NDA/BLA, EOP2 meetings, scientific advice, etc.)
Experience with investigational drugs, including late stage development and marketing application submissions
Ability to work in a cross-functional team environment with experience managing people and project teams
Strong attention to detail and the ability to handle multiple tasks
Excellent organizational, computer and documentation skills and an ability to prioritize effectively
Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
Employer will assist with relocation costs.
Internal Number: 001
About G1 Therapeutics
G1 Therapeutics is a clinical-stage biopharmaceutical company focused on discovery, development, and delivery of next generation therapies that improve the lives of those affected by cancer. The company is developing and advancing two novel therapies. Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer who are treated with chemotherapy. A New Drug Application (NDA) for trilaciclib has been assigned Priority Review by the FDA, with an action date of February 15, 2021. G1 is also advancing rintodestrant, a potential best-in-class oral selective estrogen receptor degrader, or SERD, for the treatment of ER+ breast cancer. In 2020, G1 out-licensed global development and commercialization rights to its differentiated oral CDK4/6 inhibitor, lerociclib.