Vice President, Regulatory Affairs

Company: G1 Therapeutics, Inc
Location: Durham
Posted on: April 8, 2021

Job Description:

G1 Therapeutics is a commercial-stage biopharmaceutical company focused on discovery, development, and delivery of innovative therapies that improve the lives of those affected by cancer, including its first commercial oncology product COSELA--- (trilaciclib). G1 has a deep clinical pipeline evaluating targeted cancer therapies in a variety of solid tumors, such as colorectal, breast, lung, and bladder cancers . The Opportunity: G1 Therapeutics is currently recruiting a Vice President, Regulatory Affairs to join our team in RTP, NC, reporting to Chief Medical Officer. In the role of Vice President, Regulatory Affairs, you will be responsible for developing and implementing regulatory strategies as well as coordinating all aspects of the regulatory submissions to FDA and ROW agencies for G1 Therapeutics compounds. Responsibilities:

• Develop and implement regulatory strategies for investigational and commercial drug products
• Lead activities, including planning, writing and reviewing sections of all regulatory submissions (INDs, NDAs, sNDAs, CTAs, meeting requests and briefing documents) to support clinical trials and product registration. This will require the development and management of project timelines
• Coordinate the preparation of responses to questions/information requests from US and ex-US regulatory agencies
• Act as the primary regulatory representative at internal meetings as well as meetings with business partners and US and ex-US regulatory agencies
• Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines, including IND/NDA maintenance requirements
• Monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic
• Obtain and disseminate information regarding current activities, trends, and changes in the regulatory environment
• Be familiar with CMC regulatory issues and liase with the appropriate US and ex-US CMC regulatory experts, as needed
• Be familiar with regulatory compliance and liase with the Quality Assurance group, as needed
• Function as a regulatory strategist with extensive ability to analyze complex situations and develop relevant and realistic plans for the G1 programs with appropriate risk mitigation strategies
• Foster the growth and development and provide mentorship for the regulatory affairs team
• Other duties as assigned Requirements:
  • Bachelor's degree in a scientific discipline required; advanced degree highly desired
  • Minimum of 10 years experience within oncology therapeutics
  • 15+ years regulatory industry experience in biopharmaceuticals
  • Experience with defining strategy, preparing and submitting US and ex-US marketing applications, and conducting direct interactions and negotiations with regulatory agencies (US, ex-US).
  • Previous experience in leading submission teams for clinical trial and marketing applications
  • In-depth understanding of regulatory processes, procedures, guidelines, US / Global regulatory strategy and ability to integrate into company-wide goals
  • Experience in presenting information at internal and external meetings, and regulatory agency meetings. Experience with FDA Advisory Committee meetings is desirable
  • Strong knowledge of eCTD elements and structure with regulatory writing skills
  • Strong knowledge of drug development, FDA, EMA and ICH guidelines and regulations
  • Knowledge of current Good Manufacturing Practices (cGMP)
  • Experience with Chemistry, Manufacturing and Control (CMC) related regulatory matters
  • Knowledge of promotional regulatory review requirements
  • Excellent attention to detail and problem-solving skills
  • Must be able to prioritize and deliver effectively with minimal supervision
  • Effective written and verbal communication skills required
  • Ability to work in a small, fast-paced environment covering a range of activities from document creation to high level agency interactions as the need arises
  • Demonstrated experience with effective management of contract employees, consultants and direct reports
  • Up to 15-20% travel 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. Do you now or will you in the future require sponsorship (e.g., H-1B visa status, ect.) to work legally for G1 Therapeutics in the United States?* Do you have a minimum of 10 years recent experience with oncology therapeutics?* The following questions are entirely optional. To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more .

Keywords: G1 Therapeutics, Inc, Durham , Vice President, Regulatory Affairs, Executive , Durham, North Carolina