New · posted Nov 10
Edgewise Therapeutics · Biotechnology
Senior Specialist / Manager, Regulatory Affairs
- United States
- On-site
- Full-time
- Manager
The role
This position contributes to the successful operation of the department by providing strong organization, project management, and leadership skills. As a Sr. Specialist/Manager, Regulatory Affairs, this individual will support the team with planning, preparation, and communication of regulatory activities both within the department and within cross-function teams. This role is anticipated to provide individuals with the opportunity to advance their career in regulatory affairs in a fast-paced, small company dedicated to the development of much needed therapies in cardiovascular diseases.
At Edgewise, we are focused on advancing novel, muscle-targeted therapeutics for serious cardiovascular and cardiometabolic conditions with significant unmet need. Leveraging our expertise in muscle biology and small molecule drug development, we are building a cardiovascular pipeline that includes programs for hypertrophic cardiomyopathy, heart failure and other serious cardiovascular diseases.
We’re building a passionate, experienced team committed to tackling complex scientific and clinical challenges and delivering meaningful outcomes for patients. If you’re looking to do work that matters, we’d love to hear from you.
What you need
Required Education, Experience and Skills
- BS/BA degree in a scientific/health sciences discipline .
- 3-5 years of experience in pharmaceutical Regulatory Affairs in the preparation of submissions, regulatory documents, annual reports, amendments and supplements, preferred.
- Knowledge of clinical trial conduct and regulations (ideally global) and experience working with cross-functional teams on the collection and review of required regulatory documents to support clinical trial conduct.
- Experience with reviewing clinical trial documents including investigator documents, informed consent forms, protocols and Investigator Brochures.
- Experience with electronic Regulatory Information Management systems (i.e. Veeva RIM)
- Excellent written, interpersonal and communication skills
- Able to handle changing priorities and multidisciplinary tasks
- Easily gains trust and support of peers; encourages collaboration
- Strong project management skills
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
There is no deadline because the employer accepts applications on an ongoing basis.
What you'll do
Essential Job Duties and Functions
- Supports the regulatory team with writing, editing, reviewing, and compiling documents needed for global regulatory submissions.
- Management of regulatory document management systems and maintains regulatory files.
- Provides critical review of documentation supporting regulatory submissions, communications and clinical trial conduct.
- Develops and maintains project management tools to support the regulatory team and cross functional planning.
- Develops and maintains current regulatory knowledge.
- Works with external regulatory consultants/CRO’s as required.
- Researches and identifies new opportunities outside of assigned work that augment the Company’s mission, vision, values, and goals.
- Builds professional and effective external relationships crucial to the success of the organization.
- Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders.
- Completes other duties as assigned.
Pay and benefits
$85,000 – $155,000 a year
Employer providedSalary range: $85,000-$155,000, title and salary commensurate with experience.
Health benefits
Discretionary bonus plan
Stock option grants
Stock purchase plan
401(k) with match
Paid time off
Where you'll work
United StatesOn-siteOpen in Maps (opens in a new tab)
Equal opportunity, accessibility and legal noticesEdgewise Therapeutics's statements, word for word
Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 32% below the US median for Regulatory Operations roles at this level.
This roleEmployer provided
Manager roles in the US10 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $85,000 | — | $155,000 |
| All US (middle half) | $155,375 | $176,000 | $189,250 |
This role: Edgewise Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Operations
The general path across 41 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Edgewise Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Documentation and SOPs6
- Clinical trial conduct4
- Regulatory submissions3
- GMP and compliance1
- Investigations and CAPA1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Operations work in biotechnology, each linked to the agency or standards body that publishes it.
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
- FDAFDA Structured Product Labeling(official source, opens in a new tab)The SPL standard for submitting labeling content to FDA
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- FDA21 CFR Part 601(official source, opens in a new tab)Licensing of biological products and changes to an approved BLA
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Edgewise Therapeutics on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 3
- Locations
By discipline
- Regulatory2 50%
- Clinical2 50%
By level
- Manager3 75%
- Senior & Principal1 25%
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Senior Specialist / Manager, Regulatory Affairs at Edgewise Therapeutics
Open until filled. $85K–$155K a year, employer provided.