Senior Manager/Associate Director, Regulatory Affairs CMC

About Edgewise Therapeutics:

At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.

We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!

About the Position:

This position will contribute regulatory CMC experience to Edgewise cardiovascular and skeletal muscle therapeutic development teams.

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.
• Oversees the writing, editing, reviewing and compiling 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.
• 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.
• Oversees external vendors and contractors with responsibility for providing regulatory support to ensure project deliverables are achieved.
• 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.
• 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 in rare disease is a plus
• Experience with Veeva RIM or similar document management systems ideal
• Experience in the preparation of submissions, regulatory documents, annual reports, amendments and supplements
• Proven ability to strategize with team members on the optimal way of documenting various submissions and determining the preferred plan
• Expertise on managing the timeline and process for CMC submissions
• Demonstrated knowledge of regulations and guidance affecting clinical-stage development and keeps abreast of the regulatory environment
• In-depth knowledge of overall global drug development
• Excellent written, interpersonal and communication skills
• Self-starter with experience working in a remote environment
• Action oriented and committed to meeting FDA and other regulations while moving projects forward
• Able to adapt to rapidly changing timelines and priorities
• Easily gains trust and support of peers; encourages collaboration
• Strong project management skills and initiative
  
  
  

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.

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.