[Hiring] Associate Director, Regulatory Affairs @Summit Therapeutics

Role Description

The Associate Director of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects with an in-depth knowledge and understanding of the regulatory environment. Global regulatory experience is required. These assigned projects include support of preparation and compilation of submissions for regulatory agencies, tasked clinical studies, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.

Role and Responsibilities

• Provide scientific and biological regulatory guidance to project teams and key sub-teams at the clinical study level.
• Assess, develop, and implement competitive global regulatory strategies for ivonescimab.
• Independently manage regulatory activities at the molecule and clinical study levels, including CTA and IND submissions.
• Apply broad scientific, biological, and technical knowledge in evaluating and addressing regulatory requirements.
• Present and communicate study-level regulatory activities to project teams.
• Maintain effective working relationships with regulatory agencies and subject matter experts.
• Serve as a key contributor 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 the scientific and regulatory consistency of submissions.
• Demonstrate expertise in lung cancer and other therapeutic indications.
• Oversee labelling meetings as required.
• Direct and coordinate the review and sign-off of regulatory submissions.
• Maintain and oversee the record of regulatory and ethics submissions.
• Manage document archiving processes.
• Provide cross-coverage when other team members are on leave.
• Support non-program-specific projects and other related activities.
• All other duties as assigned.

Qualifications

• BA/BS degree in Biotechnology, Biological Sciences, or related field required; graduate-level degree (MS, PhD, or PharmD) a plus.
• Relevant (bio) pharmaceutical industry experience, including a minimum of 5+ years in regulatory affairs.
• Knowledgeable of US FDA and international pharmaceutical guidance, regulations, and drug development processes.
• Experience working in a complex and matrix environment with multiple stakeholders.
• Strong written and oral communication skills in English.
• Strong negotiation skills and ability to work under pressure.
• Strong clinical foundation and understanding of the disease landscape.
• Experience interfacing with regulatory health authorities.
• Knowledge of Chinese is desirable.
• Careful attention to detail; ability to organize, prioritize, and delegate projects.
• Experience interacting with CROs in the management of ex-US CTAs preferred.
• Proficient user of standard MS Office suite and experience using electronic document management systems.

Requirements

• 5+ years of experience in regulatory affairs.
• Global regulatory experience required.
• Experience working with Health Authority.
• Experience interfacing with government regulatory agencies.

Benefits

• Compensation range: $168,000 — $198,000 USD.
• Actual compensation packages based on factors unique to each candidate.
• Total compensation may include bonus, stock, benefits, and/or other variable compensation.

Company Description

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.