Director/Senior Director, Regulatory Project Manager (EDG-2025074)

Director/Senior Director, Regulatory Project Manager 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 support the regulatory affairs team as project manager to ensure appropriate planning, cross program coordination, and regulatory milestone readiness. Essential Job Duties and Functions:

• In partnership with regulatory leads, the program management team, and functional area leaders, coordinate project plans for key submissions and regulatory milestones (e.g., new INDs/CTAs, major amendments, health authority meetings, requests for information, NDA/MAA submissions and supplements).
• Development and maintenance tracking tools that allow project visibility, clear communication of priorities, assignments, issues, and risks to project deliverables.
• Create, align cross functionally, and lead execution on marketing authorization planning activities through submission, approval and early post-approval activities.
• Lead cross-functional team meetings, including external consultants and vendors, to ensure alignment and timely execution of project plans. Identify and manage delays and risks and proactively propose remediation strategies.
• Support and emphasize a culture of accountability through clear assignments of responsibilities and program expectations.
• Routinely communicate project status and escalate risks to stakeholders.
• Ensure effective communication and collaboration between internal teams and external consultants, aligning requests/action items, status, priorities and risks to project plans.
• Contribute to inspection preparations and readiness
• 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.
• 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
• 10+ years of experience in pharmaceutical Regulatory Affairs and/or Regulatory Project Management
• Demonstrated project management expertise
• Experience with Veeva RIM would be ideal
• Management of detailed planning and timeline accountability for regulatory milestones, including marketing applications.
• Knowledge of overall global drug development, awareness of guidance and regulations and continue to develop regulatory affairs and project management expertise
• Excellent written, interpersonal and communication skills
• Able to adapt to rapidly changing priorities and multidisciplinary tasks
• Easily gains trust and support of peers; encourages collaboration
• Self-starter with experience working in a remote environment

This is a remote position. Salary range: $200,000 - $275,000, 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. Apply tot his job Apply To this Job