Global Regulatory Strategy Director

Summit Therapeutics Inc.; Northern (KY); Hybrid; USD 168,000 - 198,000; Full time

Job summary

Summit Therapeutics Inc. is seeking an Associate Director of Regulatory Affairs to lead regulatory activities for oncology programs, with global submissions experience and FDA/Health Authority liaison capabilities.

The role requires a senior regulatory professional with 5+ years in the field, capable of coordinating cross-functional teams, and delivering timely regulatory strategies, documentation, and approvals across CTAs, INDs, and BLA/MAA filings.

Qualifications

• BA/BS degree in Biotechnology, Biological Sciences, or related field required; graduate-level degree, e.g., MS, PhD, or PharmD a plus
• Relevant (bio) pharmaceutical industry experience, including a minimum of 5+ years of experience in regulatory affairs
• 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, including ability to work under pressure and proactively, and build consensus cross-functionally and within regulatory affairs
• Strong clinical foundation and understanding of disease landscape under consideration.
• Experience interfacing with regulatory health authorities
• Knowledge of Chinese is desirable
• Careful attention to detail; ability to organize, prioritize, and delegate assigned projects
• Experience interacting with CROs in the management of ex-US CTAs towards clinical trial activations preferred as well as ex-US HA interactions, meetings etc.
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable

Responsibilities

• Provides regulatory guidance on project teams and study level
• Assess, develop, and implement competitive global regulatory strategies for ivonescimab, and identify potential risks and mitigation steps with proposed strategies
• Own regulatory activities at molecule and study-level, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other day-to-day regulatory activities of the studies as necessary and independently
• Broadly applies regulatory/technical knowledge of government regulations and skills
• Present and inform study team of regulatory activities at study team meetings and provide interpretation and application of regulatory requirements
• Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provide periodic status updates regarding unfulfilled conditions and/or commitments
• Key contributor and owns the regulatory content and strategy for BLA or MAA filings
• Tracks the timelines, responsible for the regulatory dossier and manages the regulatory queries
• Health authority (HA) meetings: Serves as health authority (HA) liaison with FDA for meetings. Prepares and leads project team in the planning of regulatory meeting request and meeting package, coordinates and leads cross-functional regulatory defence preparation meetings, responses to health authority queries, and health authority meetings
• Ensure consistency, completeness, and adherence to standards for all regulatory submissions in accordance with regulatory requirements
• Demonstrate expertise and knowledge of lung cancer and other indications as needed
• Oversee labelling meetings as required
• Lead processes by which regulatory submissions are reviewed, finalized, and signed-off
• Manage the track record of regulatory/ethics submissions and approvals across all studies
• Provide cross-coverage when other members are on leave, and train new employees as needed
• Support non-program specific projects, such as department initiatives, training, etc.
• All other duties as assigned

Skills

Regulatory affairs

FDA knowledge

Stakeholder management

Clinical knowledge

Health Authority liaison

CRO coordination

Documentation management

English communications

Chinese language

Education

Biotech/ Biological sciences degree

Advanced degree (MS/PhD/PharmD) a plus

Tools

MS Office

Electronic document management systems

Job description

Summit Therapeutics Inc. is seeking an Associate Director of Regulatory Affairs to lead regulatory activities for oncology programs, with global submissions experience and FDA/Health Authority liaison capabilities.

The role requires a senior regulatory professional with 5+ years in the field, capable of coordinating cross-functional teams, and delivering timely regulatory strategies, documentation, and approvals across CTAs, INDs, and BLA/MAA filings.