New · posted Oct 15
Summit Therapeutics · Biotechnology
Senior Director, Regulatory Affairs
- Remote, US
- Remote
- Full-time
- Director
Open until filled
The role
Overview of Role
The Senior Director of Regulatory Affairs is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications (BLA/MAA) for product(s) in the oncology therapeutic area.
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.
What you need
Experience, Education and Specialized Knowledge and Skills
- Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject; Masters or Doctorate preferred
- Minimum of 10+ years' experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Japan, or China
- Experience and direct involvement as related to marketing/license applications (e.g., BLA, NDA, MAA)
- Requires drug development experience in US & EU
- Minimum of 5+ years of proven experience in a strategic leadership role with strong project management skills
- Experience working in a cross-functional environment with multiple stakeholders and influencing cross-functional teams
- Experience interfacing with major government regulatory authorities
- Strong communication and proactive negotiation skills
- Communicate effectively and articulate complex ideas in an easily understandable way
- Ability to successfully work in a fast-paced, demanding and collaborative environment
- Travel up to approximately 5%
This is the pay for this position
Pay Transparency
$203,000—$253,000 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.
What you'll do
Role and Responsibilities
- Leads global regulatory strategies for assigned products/indications through all phases of development.
- May be asked to support Regulatory Affairs as relates to development collaborations and/or partnerships and be the primary point of contact for Summit regulatory to ensure success of partner IND/CTA requirements for studies sponsored by partner
- Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers, to include development of tumor landscape assessment to inform evolving development strategy.
- Advises management and cross-functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards, etc.
- May lead the Labeling Regulatory Team for given product(s)/indication(s)
- Demonstrates excellent understanding of drug development and leadership behaviors consistent with level
- Accountable for ensuring that corporate goals are met with respect to assigned projects
- Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members
- May have direct reports and contributes to the performance management for other RA team members
- May advance the organization's goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate
- Follows budget allocations
Pay and benefits
$203,000 – $253,000 a year
Employer providedBonus
Stock
Benefits
From the posting
About Summit Therapeutics
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:
Equal opportunity, accessibility and legal noticesSummit Therapeutics's statements, word for word
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 [email protected] 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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 3% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $203,000 | — | $253,000 |
| All US (middle half) | $209,500 | $235,000 | $264,000 |
This role: Summit Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Summit Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership15
- Regulatory submissions5
- GMP and compliance1
- Documentation and SOPs1
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Summit Therapeutics on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 2
- Locations
By discipline
- Regulatory3 75%
- Quality1 25%
By level
- Director3 75%
- Manager1 25%
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Senior Director, Regulatory Affairs at Summit Therapeutics
Open until filled. $203K–$253K a year, employer provided.