Senior Manager / Associate Director, Regulatory CMC
Edgewise Therapeutics · US ·
- Seniority
- Senior
- Category
- Management
- Experience
- 5+ years
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.
This position will contribute regulatory CMC experience to Edgewise cardiovascular therapeutic development teams.
- 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.
- 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.
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.