Manager/Senior Manager/Associate Director, Regulatory Affairs

Manager/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 manages the successful operation of the department and provides regulatory expertise.

Essential Job Duties and Functions:

• Participants on project teams to provide regulatory guidance and manage completion of regulatory tasks.

• Oversees the writing, editing, reviewing and compiling 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 to FDA and European regulatory agencies.

• Reviews and prepares responses to requests from regulatory authorities.

• Provides leadership for regulatory document management systems and maintains corporate regulatory files.

• Ensures regulatory milestones are met to support regulatory submission and overall business goals of the Company,

• Research and identify new opportunities outside of assigned work that augment Company's mission, vision, values, and goals

• Oversees the external vendors and contractors with responsibility for providing regulatory support to ensure goals are achieved

• Provides operational input on project team

• 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

• 7+ years experience in pharmaceutical Regulatory Affairs

• 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

• Management expertise on the timeline and process for submissions

• Knowledge of regulations and guidance's affecting routine regulatory activities and specific therapeutic areas and keeps abreast of the regulatory environment

• Knowledge of overall global drug development

Salary range: $115,000-$195,000, 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.