DIRECTOR/SENIOR DIRECTOR, REGULATORY OPERATIONS

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!

REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

• BS/BA degree in a scientific/health sciences discipline
• 10+ years of experience in pharmaceutical Regulatory Operations.
• Strong project management skills and attention to detail
• 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.
  Salary range: $200,000 - $280,000, 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

• Provide regulatory operations leadership, including document management, publishing, submission, archiving, registration and tracking tools (e.g., INDs/CTAs/BLAs and amendments/supplements, responses to health authority requests for information, health authority briefing documents).
• Ensure compliance with current electronic submission standards and lead implementation and training on future standards.
• Plan, develop, submit, and archive regulatory packages in Veeva Regulatory Information Management (RIM) system.
• Organize, archive, and track Health Authority submissions, correspondences, and commitments.
• Collaborate with external vendors, as needed, on submission publishing activities to allow for on-time regulatory submissions in accordance with project goals and timelines.
• Develop, implement, and train on regulatory operations processes; support the broader implementation of Veeva RIM, including submission publishing.
• Monitor regulations or guidance documents and emerging technologies for potential regulatory operations impact and develop action plans accordingly. Ensures compliance with all internal and external guidelines, adhering to applicable laws and regulations.
• Ensure a consistent style of document presentation (Style Guide) to maintain quality document standards; assist in the maintenance of templates and procedures related to the formatting, publishing and archiving of submissions.
• In collaboration with other stakeholders, coordinate Disclosure, Transparency and Data sharing of information to Regulatory Authorities and the disclosure of information contained in regulatory submissions, including systems such as clinicaltrials.gov and CTIS.
• Partner with IT on the change management, release management, and ongoing validation of Veeva RIM.
• Oversee the Regulatory Operations infrastructure and development of standard operating procedures and working instructions.
• 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.