Associate Director, Regulatory Affairs
- Research Triangle Park, NC
- Full Time
G1 Therapeutics is currently recruiting an Assoc Director, Clinical Regulatory to join our team in Research Triangle Park, NC or Remote-based. Reporting to the VP, Global Regulatory Affairs the primary focus of the Associate Director, Regulatory Affairs role will be to provide support for the regulatory affairs department, with a primary focus on clinical development activities such as clinical trial activation and management, IND and CTA submissions/amendments, and health authority interactions. The role will closely interact with multiple functions leading projects and regulatory initiatives, and creating high quality regulatory submissions that support G1's product development strategy.
NOTE: This position is currently remote based, with flexibility to remain so at a future date when we resume normal business practice at our HQ office in RTP, North Carolina.
- Leading regulatory submission planning and coordination, including the preparation of regulatory submission documents, and reviewing regulatory submissions for completeness and quality in accordance with regulatory agency requirements, standards, and corporate practices
- Play a key role in the development of global regulatory strategy regarding overall development plans
- Responsible for maintaining active IND/CTAs, including timely coordination of responses to health authority questions/comments
- Representing the regulatory affairs function in study teams to provide regulatory support and advice
- Interacting with corporate partners, CROs, and vendors regarding various regulatory matters
- Providing support for regulatory interactions, including health authority meetings and teleconferences
- Ability to troubleshoot situations as needed and understands when problems need to be escalated to the VP, Global Regulatory Affairs.
- Drafting and/or modification of applicable SOPs and/or other written practices relating to the regulatory affairs function
- Other duties as assigned
- Bachelor's degree (or equivalent)
- 7+ years' experience in a regulated industry
- 5+ years' experience in regulatory affairs
- Oncology development experience expected
- Experience with clinical trial (IND/CTA) submissions and maintenance, including tracking timelines and responding to health authority questions/requests
- Strong working knowledge of global clinical trial regulatory requirements
- Comfortable with developing regulatory strategies
- Excellent written and oral communication capabilities, with strong attention to detail
- Highly organized, independent, and self-motivated with ability to multi-task
- Strong time and project management competency, with the ability to create timelines and meet deadlines
- Demonstrated ability to work within a cross-functional team and in a matrix environment
- High degree of proficiency with MS Office applications
- Experience with NDA/MAA submissions highly preferred
Why Join Us?
We know our employees are our most valuable asset, and our culture conveys that. All employees are issued laptops, and our office staff all have height-adjustable desks, access to a stocked kitchen, and multiple employee events throughout the year. We also offer a competitive benefits package, including generous PTO, to support the health and happiness of our staff.
An Equal Opportunity Employer
G1 Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at G1 Therapeutics are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.