New · posted Oct 15
Edgewise Therapeutics · Pharmaceuticals
Senior Manager / Associate Director, Regulatory CMC
- Remote, US
- Remote
- Full-time
- Manager
Open until filled
The role
This position will contribute regulatory CMC experience to Edgewise cardiovascular therapeutic development teams.
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.
- 5+ years of experience in CMC Regulatory Affairs.
- Experience with Veeva RIM or similar document management system is ideal.
- Experience in the preparation of submissions, regulatory documents, annual reports, amendments and supplements.
- Proven ability to strategize with team members in the optimal way of documenting various submissions.
- Experience with creating and managing timelines for CMC submissions; use of project management tools is a plus.
- Demonstrated knowledge of regulations and guidance affecting clinical development, registration, and lifecycle management, and staying current with Regulatory CMC trends.
- In-depth knowledge of overall global drug development.
- Excellent written, interpersonal and communication skills.
- Self-starter with experience working in a remote environment.
- Able to adapt to rapidly changing timelines and priorities.
- Easily gains trust and support of peers, is a team player, and encourages collaboration.
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
- Responsible for regulatory CMC contribution to product development and registration for small molecule investigational products. Conduct risk assessments and recommend development options.
- Contributes to the writing, editing, reviewing and compiling of CMC documents needed for regulatory submission activities for US and global assigned products. The submissions include IMPD, INDs, CTAs, NDAs, MAAs, meeting requests, briefing documents, and annual reports, as well as contribution from a CMC perspective on other submissions and clinical documents.
- Provides critical review of CMC documentation supporting regulatory submissions and communications and oversees data verification/QC.
- Collaborate cross-functionally with Regulatory Affairs, CMC, and Quality to ensure compliance such as manufacturing records review, release and change controls.
- Prepares regulatory submissions using regulatory document management systems and archival of regulatory documentation.
- Ensures CMC regulatory milestones are met to support regulatory submission and overall business goals of the Company.
- Contribute to the development of the overall regulatory strategies.
- May oversee external vendors and contractors with responsibility for providing regulatory support to ensure project deliverables are achieved.
- Builds professional and effective internal and external relationships crucial to the success of the programs.
- Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders.
- Other duties as assigned.
Pay and benefits
$150,000 – $210,000 a year
Employer providedSalary range: $150,000-$210,000, title and salary commensurate with experience
Health benefits
Discretionary bonus plan
Stock option grants
Stock purchase plan
401(k) with match
Paid time off
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 · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% above the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Manager roles in the US15 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $150,000 | — | $210,000 |
| All US (middle half) | $157,000 | $171,000 | $180,750 |
This role: Edgewise Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Edgewise Therapeutics's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Documentation and SOPs7
- Regulatory submissions7
- GMP and compliance2
- Quality systems and risk2
- Investigations and CAPA1
- Data and digital systems1
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.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Edgewise Therapeutics on Regulatory Jobs
- 1
- Open roles
- 1
- Distinct roles
- 1
- Locations
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Senior Manager / Associate Director, Regulatory CMC at Edgewise Therapeutics
Open until filled. $150K–$210K a year, employer provided.