Senior Manager, Regulatory Affairs

About Summit

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. At Summit we believe in building a team of world class professionals who are passionate about this mission and it is our people who drive this mission to reality. Summits core values include integrity passion for excellence purposeful urgency collaboration and our commitment to people. Our employees are truly the heart and soul of our culture and they are invaluable in shaping our journey toward excellence.

Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies including:

Non-small Cell Lung Cancer (NSCLC)

• HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

• HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

• HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland.

Overview of Role:

Reporting to Head of Regulatory Affairs the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. 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 ownership of molecule and study-level regulatory activities including global clinical trial applications (CTAs) and IND submissions review and approval of investigator document packages and associated FDA submissions and manage other regulatory aspects of the studies as necessary
• Contribute and drive the regulatory content and strategy for BLA NDA or marketing authorization submissions
• Provide regulatory guidance internally on study-team decisions
• Update study team of regulatory activities in the context of study team management meetings
• 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/commitments
• Collaborate with cross-functional study team for planning of regulatory documents including health authority meetings and responses to health authority queries
• Support processes by which regulatory submissions are reviewed finalized and signed-off
• Manage the record of regulatory/ethics submissions and approvals across all studies
• Manage document archive processes
• Support global regulatory submissions and strategic planning as applicable
• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• BA/BS degree in the biological or health related sciences required Masters PhD or PharmD preferred
• Minimum of 3 years of experience in regulatory affairs
• Minimum of 7 years of pharmaceutical biotechnology or life sciences industry experience
• Knowledgeable of US FDA and international pharmaceutical guidances regulations drug development process and industry-standard practices
• Possess strong written oral communications
• Demonstrate proven interpersonal skills and experience working cross-functionally throughout the organization
• Detail-oriented ability to work proactively 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 health authority 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
• Knowledge of Chinese is desirable

The pay range for this role is $174000-$204000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.