Associate Director, Regulatory Affairs

The role

The Associate Director of Regulatory Affairs supports day-to-day regulatory activities for assigned projects. This role involves preparing and compiling submissions for regulatory agencies and managing regulatory submission processes and timelines.

What you will do

• Provide scientific and biological regulatory guidance to project teams.
• Assess, develop, and implement competitive global regulatory strategies for ivonescimab.
• Manage regulatory activities at the molecule and clinical study levels including CTA and IND submissions.
• Review and approve investigator document packages and associated FDA submissions.
• Present and communicate study-level regulatory activities to project teams.
• Maintain working relationships with regulatory agencies and subject matter experts.
• Assume ownership of scientific and regulatory content for BLA and MAA filings.
• Track regulatory timelines and manage regulatory queries.
• Serve as Summit's liaison with the FDA for health authority meetings.
• Ensure scientific and regulatory consistency and adequacy of regulatory submissions.

Required qualifications

• BA/BS degree in Biotechnology, Biological Sciences, or related field
• Minimum of 5+ years of experience in regulatory affairs in (bio) pharmaceutical industry
• Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry-standard practices
• Experience working in a complex and matrix environment, and with multiple stakeholders
• Experience interfacing with government regulatory agencies
• Experience working with Health Authority
• Strong written, oral communications in English
• Strong negotiation skills
• Strong clinical foundation and understanding of disease landscape under consideration
• Experience in interfacing with regulatory health authorities
• Careful attention to detail
• Ability to organize, prioritize, and delegate assigned projects

Nice to have

• graduate-level degree, e.g., MS, PhD, or PharmD
• Knowledge of Chinese is desirable
• Experience interacting with CROs in the management of ex-US CTAs towards clinical trial activations preferred
• ex-US HA interactions, meetings etc. preferred
• experience using electronic document management systems, and document review tools desirable

Benefits

• bonus
• stock
• benefits

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.