Associate Director, Regulatory Affairs

Summit Therapeutics

2h•$168,000 - $198,000

About The Position

The Associate Director of Regulatory Affairs supports day-to-day regulatory activities for assigned projects, applying in-depth knowledge of the regulatory environment and global regulatory experience. The role supports preparation and compilation of agency submissions, assigned clinical studies, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure. The position provides scientific and biological regulatory guidance to project teams and develops and implements global regulatory strategies for ivonescimab. It independently manages regulatory activities at the molecule and clinical-study levels, including CTA and IND submissions, investigator document packages, agency interactions, and regulatory commitments. The role also owns scientific and regulatory content and strategy for BLA and MAA filings, serves as Summit’s FDA liaison for health authority meetings, and coordinates cross-functional preparation for meetings and agency responses. The Associate Director ensures regulatory submissions are scientifically and technically consistent, complete, and compliant with applicable requirements and submission standards. Other responsibilities include oversight of labeling meetings, regulatory and ethics submission records, document archiving, cross-coverage and training, and support for departmental and other non-program-specific projects. Summit Therapeutics is a biopharmaceutical oncology company headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.

Requirements

BA/BS degree in Biotechnology, Biological Sciences, or a related field.
At least 5 years of relevant biopharmaceutical industry experience in regulatory affairs.
Knowledge of US FDA and international pharmaceutical guidance and regulations, the drug-development process, and industry-standard practices.
Experience working in complex, matrixed environments with multiple stakeholders.
Experience interfacing with government regulatory agencies and health authorities.
Strong written and oral communication skills in English.
Strong negotiation skills; ability to work proactively under pressure and build consensus across functions and within regulatory affairs.
Strong clinical foundation and understanding of the relevant disease landscape.
Careful attention to detail and ability to organize, prioritize, and delegate assigned projects.

Nice To Haves

Graduate-level degree, such as an MS, PhD, or PharmD.
Knowledge of Chinese.
Experience interacting with CROs to manage ex-US CTAs toward clinical trial activation, as well as ex-US health authority interactions and meetings.
Proficiency with standard Microsoft Office applications such as Word and Excel.
Experience with electronic document management systems and document review tools.

Responsibilities

Provide scientific and biological regulatory guidance to project teams and key sub-teams at the clinical-study level.
Assess, develop, and implement global regulatory strategies for ivonescimab, considering scientific and biological aspects, regulatory requirements, risks, and mitigation strategies.
Independently manage molecule- and clinical-study-level regulatory activities, including CTA and IND submissions, investigator document packages, FDA submissions, and other day-to-day regulatory activities.
Apply scientific, biological, and technical knowledge and applicable government regulations to regulatory requirements throughout clinical development.
Present and communicate study-level regulatory activities and interpret regulatory requirements for project teams.
Maintain working relationships with regulatory agencies and subject matter experts; coordinate written responses to agency queries, track commitments, and communicate progress on outstanding conditions and commitments.
Own scientific and regulatory content and strategy for BLA and MAA filings.
Track regulatory timelines, maintain the regulatory dossier, and manage regulatory queries.
Serve as Summit’s FDA liaison for health authority meetings and lead cross-functional preparation of meeting requests, meeting packages, agency responses, defense-preparation sessions, and meetings.
Ensure regulatory submissions are scientifically and regulatorily consistent, complete, adequate, and compliant with applicable requirements and submission standards.
Apply knowledge of lung cancer and other therapeutic indications to regulatory oversight and clinical development.
Oversee labeling meetings, considering applicable scientific, clinical, and regulatory requirements.
Direct and coordinate review, finalization, and sign-off of regulatory submissions.
Maintain and oversee records of regulatory and ethics submissions and approvals across clinical studies.
Manage document archiving to maintain scientific and regulatory documentation and ensure its accessibility.
Provide cross-coverage when team members are on leave and train new employees on regulatory processes, scientific and biological regulatory requirements, and submission procedures.
Support non-program-specific projects, including departmental initiatives and scientific and regulatory training.
Perform other duties as assigned.