Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted 2 days ago

Senior Specialist, Regulatory Operations

Summit Therapeutics81 open roles

Pay
$122,000 – $143,000 a year
Where
Remote (US)
Work mode
Remote
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowSenior Specialist, Regulatory OperationsSummit Therapeutics · Remote (US)

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Summit Therapeutics's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market. Summit Therapeutics postings stay open a median of 15 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: posted 2 days ago

Summit Therapeutics median: 15 days open

The posting

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 Senior Specialist, Regulatory Operations provides hands-on technical preparation and publishing of regulatory submissions, including eCTD packages, and supports submissions to assigned health authorities. The role manages the operational execution of assigned routine submissions and supports larger or complex filings under another Regulatory Operations Submission Manager (RSM). This position also prepares submission-ready documents, follows up on content readiness and milestones, maintains accurate Veeva RIM records, and supports submission-related projects and system activities.

Role and Responsibilities:

Submission preparation and execution

  • Serve as the assigned RSM for routine IND, CTA, application lifecycle, meeting, and Health Authority response submissions. Support complex or high-priority filings under the direction of the assigned RSM.
  • Maintain assigned submission plans, content trackers, deliverable dates, and readiness status with the Regulatory Lead and project team. Follow up with Document Owners on expected handoffs, document status, and open actions; provide updates and escalate risks to the Regulatory Lead and, when applicable, the lead RSM.
  • Prepare submission-ready Word and PDF documents, including formatting, conversion, bookmarks, hyperlinks, and technical checks. Identify content changes needed after handoff and route them to the Document Owner and Regulatory Lead for review and reapproval.
  • Compile, publish, and validate eCTD and non-eCTD packages using approved tools and current regional specifications. Perform document-level technical QC, resolve publishing or validation findings with responsible stakeholders, and support global submission delivery as assigned.
  • When qualified and independent of package preparation, perform submission-level QC for packages prepared by others. For assigned submissions, confirm technical readiness, transmit or deliver only after Regulatory Lead authorization, track acknowledgments or delivery status, resolve technical rejections, and archive final records.

RIM and cross-functional support

  • Create and maintain accurate application, regulatory objective, submission, document, metadata, milestone, and Health Authority correspondence records in Veeva RIM. Support workflows, data quality, user issue triage, and assigned system changes in coordination with the RIM business owner, IT, and Quality.
  • Provide technical support for promotional submissions, including Form FDA 2253, when assigned. Coordinate with the Regulatory Lead, promotional content owners, and PromoMats users to obtain approved versions and required package materials.
  • Support submission-related projects through action tracking, meeting follow-up, and status reporting. Participate in assigned RIM migration, user acceptance testing, training, work instruction updates, and process improvements; perform other related duties as assigned.

Required Qualifications

  • Bachelor's degree in life sciences or a related discipline. Master’s in Regulatory Affairs Highly Desired.
  • A minimum of 4 years of Regulatory Operations experience in pharmaceutical or biotechnology, including hands-on document preparation, eCTD publishing, and submission support.
  • Working knowledge of eCTD lifecycle management, applicable FDA and ICH technical standards, publishing validation, and document- and submission-level technical QC.
  • Strong Microsoft Word and Adobe Acrobat skills, including document formatting, PDF preparation, bookmarking, hyperlinking, and troubleshooting.
  • Experience using a RIM or comparable validated document and submission management system, with attention to accurate metadata and records.
  • Ability to organize concurrent deliverables, follow up across functions, communicate risks promptly, and work independently within assigned responsibilities.

Preferred Qualifications

  • Experience with Veeva RIM, Veeva PromoMats, or a comparable promotional content workflow.
  • Experience supporting submissions outside the United States or preparing Form FDA 2253 and postapproval submissions.
  • Experience with system migration, user acceptance testing, work instructions, or submission project tracking.

This is the pay for this position

Pay Transparency

$122,000—$143,000 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 [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.

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Summit Therapeutics's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Summit Therapeutics's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Summit Therapeutics's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.