Senior Specialist / Manager, Regulatory Affairs

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 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.

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.

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

Salary range: $85,000-$155,000, 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.