Jobs in the United States

25+ jobs

Save this search

Added just now
Senior Cost Manager / Quantity Surveyor - Data Center Construction
Turner & Townsend
Richmond, VA
…to support the delivery of a major data center construction program. This role will serve as a key client-facing lead, providing expert cost management, quantity surveying, commercial…
Added 1 min ago
LA
PUBLIC AFFAIRS AND COMMUNICATIONS OFFICER
Los Angeles County Development Authority
Alhambra, CA
- $54.71 to $82.07 USD / hour
…Officer strengthens the LACDA’s visibility, supports policy and program goals, and maintains consistent messaging aligned with the agency’s strategic…
Added 1 min ago
TN
Director of Development, South Carolina
The Nature Conversancy
North Charleston, SC · Greenville, SC
- $130,000 to $160,000 USD / year
The Director of Development II will work towards meeting the strategic priorities of the program by conceiving, developing, and managing plans and strategies. They focus on long-range…
Added 1 min ago
Assistant Manager, Brand Activation & Commercial Impact, Estee Lauder & Aerin Beauty - North America
Estée Lauder Companies
New York
Sitting within the North America Consumer Engagement (Comms/PR) team, this role will lead the day-to-day development and execution of consumer experiences while activating creator-led…
Added 1 min ago
Executive Director Global Supplier Management
Estée Lauder Companies
United States
…design/value thinking across brands and categories, cross-function program management, enterprise savings digital management platforms, standardized value creation operating model, and…
Added 1 min ago
CSEL Program - Project Engineer (Lead or Senior)
The Boeing Company
Huntington Beach, CA
…(SI&WS)’s CSEL CLS Engineering team is currently looking for a Project Engineer (Lead or Senior) to join their program in Huntington Beach, CA. This organization supports Boeing’s Combat…
Added 1 min ago
Flight Software Test Engineers (Associate/Experienced/Senior)
The Boeing Company
El Segundo, CA
Participates in software project management activities related to test and verification, coordinating with multifunctional teams to meet schedule and quality objectives.
Added 2 mins ago
SAP Basis Administrator - Onsite in St. Louis, MO
Accenture
Saint Louis, MO
+ Lead efforts to troubleshoot and/or resolve software, operating system, and networking problems
Added 3 mins ago
Sr. Clinical Contracts Manager
Augusta Life Sciences US OpCo I LLC
Remote, United States
Global Contract Management: Lead the preparation, negotiation, execution, and management of clinical research agreements including CTAs, CSAs, CDAs, DPAs, image transfer agreements, and…
Added 3 mins ago
Program Director, Roads and Highways, Houston
Parsons Transportation Group
TX
The Mobility Solutions Market provides planning, design, program management, construction management, and software solutions to a wide range of infrastructure clients, mainly in North…
Added 4 mins ago
FL
Director of Protective Operations and Logistics
FMR LLC
United States
- $95,000 to $186,000 USD / year
…Protection team, you will be responsible for executive protection program management and logistical planning, including staffing, scheduling, protective transportation operations, support…
Added 4 mins ago
Finance Manager, FP&A/Client Finance
We. Communications
Oregon • Seattle, WA · Seattle, WA
Lead month-end close activities for the client account, including revenue, costs, accruals, intercompany activity, and project financials.
Added 5 mins ago
Physical Scientist
Department Of Energy
Carlsbad, NM
Summary This position is part of the Office of Environmental Management - Carlsbad Field Office, Department of Energy. As a Physical Scientist, you will be managing the National Transuranic…
Added 5 mins ago
General Engineer
Department Of Energy
Carlsbad, NM
Summary This position is part of the Office of Environmental Management - Carlsbad Field Office, Department of Energy. As a General Engineer, you will be managing the National Transuranic…
Added 5 mins ago
MS
Senior Principal Scientist
Mission Support and Test Services
Los Alamos, NM
- $147,804.8 to $229,091.2 USD / year
We are looking for a Senior Principal Scientist to collaborate with the project lead on the design, development, characterization, and fielding of diagnostic and scientific systems that…
Added 5 mins ago
Senior Software Engineer | Rocky Program
The Boeing Company
Albuquerque, NM
Experience as a Technical Lead Engineer (TLE), Software Lead, Software Architect, and/or Chief Engineer on a complex software development project/program
Added 5 mins ago
Cleared Experienced RD Systems Engineer - ISA Data Management Lead, Onsite
Sandia National Laboratories
Albuquerque, NM
The opportunity exists for an experienced R&D Systems Engineer to lead Integrated Surety Architectures (ISA) data management activities. The ISA program has qualified multiple systems in…
Added 5 mins ago
Senior Governance Program Manager (Open to ND/MN Only)
Razor
Fargo, ND
5–7+ years of experience in technical program management, product or project management, business operations, governance, or a related discipline
Added 5 mins ago
Subcontracts Administrator
Serco
Santa Fe, NM
Lead a program team in subcontractor negotiations concerning price, terms, and delivery schedule.
Added 5 mins ago
Senior IT Project Manager (NSGS)
GovCIO
Santa Fe, NM
GovCIO is seeking a Senior IT Project Manager to support mission-critical infrastructure modernization programs for the U.S. Coast Guard (USCG). This position will serve as a key technical…
Added 5 mins ago
VP, Finance Excellence and Transformation
Amentum
Santa Fe, NM
Lead the end-to-end strategy, planning, and execution of an enterprise-wide finance transformation program.
Added 5 mins ago
C
Senior Java Full Stack Engineer – Spring Boot & AWS
Cognizant
Santa Fe, NM
- $86,000 to $99,000 USD / year
Lead the design and development of scalable full-stack applications using Java, Spring Boot, React, and AWS, applying cloud-native and microservices architecture patterns.
Added 6 mins ago
Customer Success Manager
Nortek Air Solutions, LLC
Remote, United States
3+ years of experience in customer success, account management, project management, supply chain, order management, operations, or a related customer-facing role.
Added 8 mins ago
MC
Senior Planner
Metropolitan Council
St Paul, MN
- $42.58 to $69.09 USD / hour
…work unit implements the Act through the Sector Representative Program and reviews comprehensive plans, amendments to those plans, and environmental reviews, which deal with an array of…
Added 8 mins ago
MC
Rail Maintenance Supervisor (Overhaul)
Metropolitan Council
Minneapolis, MN
- $42.9 to $69.63 USD / hour
A high school diploma/GED AND eight (8) years of experience, including one (1) year of supervisory, project management, or lead experience*.

Summit Therapeutics

Associate Director, Regulatory Affairs

Remote, United States

$168,000 - $198,000 USD

Apply About employer

Applications open in a new tab.

Job details

Pay: $168,000 - $198,000 USD
Education: Doctoral degree
Experience: Relevant (bio) pharmaceutical industry experience, including a minimum of 5+ years of experience in regulatory affairs
Posting language: English
Posted: Sep 8, 2026

Original job description

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. Summit’s 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.

Summit’s team is inspired to touch and help change lives through Summit’s 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 China’s 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:

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, applying knowledge of biological sciences and the regulatory requirements governing the clinical development of biological therapeutics.
Assess, develop, and implement competitive global regulatory strategies for ivonescimab, taking into consideration the biological and scientific aspects of the therapeutic, applicable regulatory requirements, and potential risks and mitigation strategies.
Independently manage regulatory activities at the molecule and clinical study levels, including Clinical Trial Application (CTA) and Investigational New Drug (IND) submissions; review and approve investigator document packages and associated FDA submissions; and oversee other day-to-day regulatory activities associated with the clinical development of the biological therapeutic.
Apply broad scientific, biological, and technical knowledge, together with an understanding of applicable government regulations, in evaluating and addressing regulatory requirements throughout the clinical development process.
Present and communicate study-level regulatory activities to project teams, providing interpretation and application of regulatory requirements in the context of the scientific and biological aspects of the clinical studies.
Maintain effective working relationships with regulatory agencies and subject matter experts to coordinate written responses to agency queries, track regulatory commitments, and communicate progress on outstanding conditions and commitments relating to the clinical development and regulatory oversight of the therapeutic.
Serve as a key contributor and assume ownership of the scientific and regulatory content and strategy for Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings.
Track regulatory timelines, maintain responsibility for the regulatory dossier, and manage regulatory queries to ensure the accurate and complete presentation of the scientific and regulatory information supporting the therapeutic.
Serve as Summit's liaison with the FDA for health authority meetings. Lead cross-functional teams in preparing regulatory meeting requests, meeting packages, and responses to agency queries; coordinate and lead regulatory defense preparation sessions and health authority meetings concerning the clinical development and regulatory status of the therapeutic.
Ensure the scientific and regulatory consistency, completeness, and adequacy of regulatory submissions and their adherence to applicable regulatory requirements and submission standards.
Demonstrate expertise and knowledge of lung cancer and other therapeutic indications as needed, applying such knowledge in connection with the regulatory oversight and clinical development of the therapeutic.
Oversee labelling meetings as required, ensuring appropriate consideration of applicable scientific, clinical, and regulatory requirements.
Direct and coordinate the review, finalization, and sign-off of regulatory submissions to ensure the completeness and adequacy of the scientific and regulatory information presented.
Maintain and oversee the record of regulatory and ethics submissions and approvals across all clinical studies.
Manage document archiving processes to ensure the appropriate maintenance and accessibility of scientific and regulatory documentation.
Provide cross-coverage when other team members are on leave and train new employees as needed on regulatory processes, applicable scientific and biological regulatory requirements, and submission procedures.
Support non-program-specific projects, including departmental initiatives, scientific and regulatory training, and other related activities.
All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

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 in 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 Education

This is the pay for this position

Pay Transparency

$168,000 - $198,000 USD

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 Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Apply About employer

More about this job

Skills

Regulatory affairs
Documentation
Biotechnology
Pharmaceutical industry
Negotiation
Cope with pressure
Attention to detail
CTAS
Microsoft Office
Microsoft Word
Microsoft Excel
Document management

Report this job