Associate Director/Director, Regulatory Affairs

Associate Director / Director, Regulatory Affairs (EU- or UK-based)

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 to the build-out of the regulatory affairs function at Edgewise and will provide regulatory expertise from preclinical through clinical development for our programs. This EU- or UK-based position will assume a broad range of responsibilities including managing the development of regulatory strategies and submissions.

Essential Job Duties and Functions:

• Contribute to the development of global regulatory strategies and provide expertise on planning and execution of development programs with EMA and MHRA.
• Responsible for regulatory clinical trial applications, annual reports, IND and IMPD amendments, and meeting requests to regulatory agencies.
• Oversee the writing, editing, reviewing, and compiling of documents needed for regulatory submission activities for US and global assigned products. Expertise in Clinical Trials Regulation, Clinical Trials Information System (CTIS), and associated databases.
• Provide critical review of all documentation supporting regulatory submissions and communications.
• Act as primary liaison with regulatory agencies. Reviews and prepares responses to information requests from regulatory authorities.
• Utilize Veeva RIM to maintain accurate and complete corporate regulatory files.
• Provide strategic or operational input on project teams. Stays informed and advises on evolving regulations.
• Effectively manages the activities of assigned external vendors and contractors, as appropriate.
• Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders.
• Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
• Perform other duties as assigned by supervisor.

Required Education, Experience and Skills:

• BS/BA degree in a scientific/health sciences discipline.
• 7+ years of experience in pharmaceutical Regulatory Affairs. Expertise in Clinical Trials Regulation, Clinical Trials Information System (CTIS), and associated databases.
• Strong project management skills and attention to detail.
• Experience interacting with MHRA and EMA.
• Experience using Veeva Regulatory Information Management (RIM) system, including Submissions Publishing.
• Experience formatting and structuring submissions to meet agency requirements, including electronic submission standards.
• Excellent written, interpersonal and communication skills.
• Able to handle changing priorities and multidisciplinary tasks.
• Easily gains trust and support of peers; encourages collaboration.

This is a remote position based either in the EU or UK.

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.