Senior Specialist / Manager, Regulatory Affairs
Edgewise Therapeutics
Summary
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.
Job description
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.
Requirements
- 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)
- 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
Benefits
- Health benefits
- Discretionary bonus plan
- Stock option grants
- Stock purchase plan
- 401(k) with match
- Paid time off
Company overview
Edgewise Therapeutics, Inc. (NASDAQ: EWTX) is a leading muscle disease biopharmaceutical company dedicated to developing novel therapeutics for serious skeletal and cardiac muscle diseases. Founded in 2017 and headquartered in Boulder, Colorado, the company focuses on addressing unmet medical needs in muscular dystrophies (including Becker and Duchenne muscular dystrophy) and serious cardiac conditions such as hypertrophic cardiomyopathy. Edgewise combines its foundational expertise in muscle biology with small molecule drug discovery through its proprietary muscle-focused platform. The company's lead candidate, sevasemten, is an orally administered first-in-class fast skeletal myosin inhibitor currently in clinical development. With a patient-centric approach and a team of 51-200 employees, Edgewise is advancing precision therapeutics that aim to transform the lives of patients and families affected by serious muscle diseases. The company's vision is to build the world's leading muscle-focused biopharmaceutical organization through innovative science and courageous commitment to addressing life-limiting muscle conditions.