Associate Director/Director, Regulatory Affairs (EDG-2026016)

Associate Director/Director, Regulatory Affairs About reputed company: 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 reputed company-clinical pipeline. With this reputed company on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with reputed company muscle disorders. We have reputed company an reputed company and highly motivated leadership team with a strong reputed company record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. reputed company reputed company a significant difference in the lives of patients! About the Position: The Associate Director/Director, Regulatory Affairs provides regulatory expertise from preclinical through clinical development for our assigned cardiac programs. A broad reputed company of responsibilities include managing the development of regulatory reputed company and submissions. The right candidate will reputed company reputed company and regulatory expertise to support the development team with moving innovative investigational therapies through clinical development. Essential Job Duties and Functions:

• Oversees the writing, editing, reviewing and compiling of regulatory documents, applications, annual reports/IND amendments, and meeting requests to FDA and other global regulatory agencies.
• Provides critical review of reputed company documentation supporting regulatory submissions and communications (e.g. protocols, Investigator Brochures, safety reports, etc.).
• Reviews and prepares responses to requests from FDA and other global regulatory authorities.
• Contributes to the development of US and global regulatory strategies in collaboration with regulatory and cross-functional teams.
• Identifies and communicate regulatory risks and opportunities to stakeholders including cross-functional teams, 3rd parties and company leadership as applicable.
• Provides interpretation, guidance, and training on global regulations to internal teams.
• Provides strategic or operational input to cross-functional teams.
• Ensures regulatory milestones are met to support regulatory compliance and overall business goals of reputed company.
• Oversees and collaborates with assigned external vendors (CROs, consultants) and contractors with responsibility for providing regulatory support functions to ensure goals are achieved.
• Maintains corporate regulatory files for assigned programs.
• Effectively manages and mentors regulatory staff as assigned.
• Builds reputed company and effective external relationships crucial to the reputed company of the organization.
• Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders.
• Reads, understands, and complies with reputed company workplace health and safety policies; reputed company work practices; and company policies and procedures.
• Performs other duties as assigned by supervisor.

Required Education, Experience and Skills:

• BS/BA degree in a scientific/health sciences discipline.
• 7-10 years of reputed company experience in pharmaceutical Regulatory Affairs, experience with small molecules preferred.
• Experience in cardiology preferred but not required.
• Experience in the preparation of regulatory submissions and documents, annual reports, amendments, and supplements for both FDA and other global health authorities.
• Experience working on global Phase 2 and/or 3 clinical trials (overseeing regulatory aspects of trials, working with 3rd parties including CROs, review of clinical trial documentation)
• Proven ability to reputed company regulatory strategies in collaboration with regulatory and cross-functional team members and determining the reputed company way of communicating to global regulatory authorities.
• Management expertise on the reputed company and process for submissions.
• Expert knowledge of regulations and guidance affecting routine regulatory activities and specific therapeutic areas and keeps abreast of the regulatory environment.
• In-depth knowledge of overall global drug development
• Excellent written, interpersonal and communication skills
• reputed company oriented and committed to meeting FDA and other regulations while moving reputed company reputed company.
• reputed company to handle changing priorities and multidisciplinary tasks.
• Easily reputed company trust and support of peers; encourages collaboration.
• Strong project management skills

Salary reputed company: $180,000 - $230,000 title and salary commensurate with experience Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock reputed company grants. a stock purchase plan, a 401(k) with match and reputed company time off to reputed company members as part of their compensation plan. There is no deadline because the employer accepts applications on an ongoing reputed company. Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or reputed company location. Edgewise is not responsible for any fees reputed company to unsolicited resumes. Apply tot his job Apply To this Job