Senior Manager / Associate Director, Regulatory CMC

Edgewise Therapeutics, Inc.; United States; Remote; USD 150,000 - 210,000; Full time

Benefits offered by this job

Health benefits

Discretionary bonus plan

Stock option grants

Stock purchase plan

401(k) with match

Paid time off

Job summary

Edgewise Therapeutics, Inc. seeks a senior CMC Regulatory Affairs professional to contribute regulatory CMC expertise to cardiovascular programs.

The role supports US and global submissions, engages with Regulatory, CMC, and Quality teams, and guides submission strategies to meet milestones. Ideal candidates will have 5+ years in CMC Regulatory Affairs, experience with regulatory documents, and a track record of coordinating cross-functional teams in a remote work environment.

Qualifications

• 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.
• Experience in preparing regulatory submissions and regulatory documents.
• Knowledge of global regulatory trends and lifecycle management.

Responsibilities

• Contribute regulatory CMC input to product development and registration efforts for small molecules.
• Prepare and compile CMC documents for US and global submissions (IMPD, INDs, CTAs, NDAs, MAAs, briefing documents).
• Review CMC documentation for regulatory submissions and QC.
• Collaborate with Regulatory Affairs, CMC, and Quality to ensure compliance and change controls.
• Develop regulatory submission strategies and manage timelines; coordinate with vendors as needed.

Skills

CMC Regulatory Affairs

Regulatory submissions

Cross-functional work

Remote work experience

Regulatory strategy

Education

BS/BA in science/health sciences

Tools

Veeva RIM

Job description

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.

About the Position:

This position will contribute regulatory CMC experience to Edgewise cardiovasculartherapeutic development teams.

Essential Job Duties and Functions:

• Responsible for regulatory CMC contribution to product development and registrationfor small molecule investigational products. Conduct risk assessments and recommenddevelopment options.
• Contributes to the writing, editing, reviewing and compiling of CMC documents neededfor regulatory submission activities for US and global assigned products. Thesubmissions include IMPD, INDs, CTAs, NDAs, MAAs, meeting requests, briefing documents, and annual reports, as well as contribution from a CMC perspective on othersubmissions and clinical documents.
• Provides critical review of CMC documentation supporting regulatory submissions andcommunications and oversees data verification/QC.
• Collaborate cross-functionally with Regulatory Affairs, CMC, and Quality to ensurecompliance such as manufacturing records review, release and change controls.
• Prepares regulatory submissions using regulatory document management systems andarchival of regulatory documentation.
• Ensures CMC regulatory milestones are met to support regulatory submission andoverall business goals of the Company.
• Contribute to the development of the overall regulatory strategies.
• May oversee external vendors and contractors with responsibility for providingregulatory 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.

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.

Salary range: $150,000-$210,000, title and salary commensurate with experience

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.