About the Company
Our client, a clinical-stage biotechnology company developing unique oncologic drugs treatments, is currently seeking a Head of Regulatory Affairs to join their rapidly growing team. The Regulatory Affairs head will be a key leader of the management team and will support the development and implementation of regulatory strategies and processes to secure worldwide product approvals.
- Leading the integration of Regulatory Affairs across all the operative functions related with clinical development, CMC, devices, quality assurance and future product commercial launch initiatives.
- Clinical trial design including trial design for accelerated approvals
- Pharmacovigilance and drug safety compliance
- Regulatory submissions and discussions with the FDA, EMA and PMDA
- CMC/cGMP of biologics to support pivotal studies and commercial launch, device regulatory compliance for world-wide use
- Commercial launch and product promotional activities.
- Serving as point of contact and represent the Company before regulatory authorities, including preparation of meeting agendas, materials, and minutes.
- Managing and overseeing all operational aspects of regulatory submissions
- Providing counsel, training, and interpretation of FDA and other regulatory agencies to Company personnel
Share This Position:
- Minimum of 10 years of regulatory experience in US/OUS (EU/Japan) related with pharmaceutical/device development and commercialization
- Experience in oncology programs and accelerated approvals
- B.S. / M.S. degree or higher in a life science field is minimum. Ph.D. or equivalent is highly desired. RAC accreditation is desirable
- Experience in interfacing with the FDA, EMA and PDMA
- Experienced in cGMP of biologics
- Extensive knowledge of US FDA/EMA drug/device development process, regulations and guidelines