Senior Manager/Associate Director, Regulatory Affairs

Senior Manager/Associate Director, Regulatory Affairs

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 contributes to the successful operation of the Regulatory Affairs department and provides regulatory guidance at the cross-functional team level.

Essential Job Duties and Functions:

• Participates on cross-functional teams to provide regulatory input and manage completion of regulatory tasks.
• Manages the writing, editing, reviewing and compiling of documents needed for regulatory submission activities for US and global assigned products.
• Provides critical review of all documentation supporting regulatory submissions and communications.
• Prepares and submits regulatory applications, annual reports/IND amendments, and meeting requests/packages to FDA and global regulatory agencies.
• Reviews and prepares responses to requests from regulatory authorities.
• Accountable for maintenance and archival of regulatory documents and correspondence.
• Ensures regulatory milestones are met to support regulatory submission and overall business goals of the Company.
• 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 pharmaceutical Regulatory Affairs
• Experience independently managing the preparation and maintenance of regulatory submissions, documents, annual reports, and amendments
• Experience contributing as a regulatory representative on cross-functional clinical trial teams and working with Clinical Research Organizations, ideally for global Phase 2 or Phase 3 studies.
• Experience reviewing and providing regulatory input on clinical trial related documents and issues.
• Self-starter with experience working in a remote environment
• Proven ability to strategize with team members on the optimal way of documenting various submissions and determining the preferred plan
• Management of the timeline and process for regulatory submissions
• Effectively able to identify and communicate risk and develop mitigation strategies
• Knowledge of regulations and guidance affecting routine regulatory activities and keeps abreast of the regulatory environment
• Knowledge of overall global drug development requirements
• Excellent written, interpersonal and communication skills
• Action oriented and committed to meeting FDA and other regulations while moving projects forward
• Able to handle changing priorities and multidisciplinary tasks
• Easily gains trust and support of peers; encourages collaboration
• Strong project management skills

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.