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

Role Summary

The Associate Director/Director, Regulatory Affairs provides regulatory expertise from preclinical through clinical development for our assigned cardiac programs. A broad range of responsibilities include managing the development of regulatory strategy and submissions. The right candidate will provide oversight and regulatory expertise to support the development team with moving innovative investigational therapies through clinical development.

Responsibilities

• 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 all 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 the 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 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.
• Reads, understands, and complies with all workplace health and safety policies; safe work practices; and company policies and procedures.
• Performs other duties as assigned by supervisor.

Qualifications

• Required: BS/BA degree in a scientific/health sciences discipline.
• Required: 7-10 years of progressive experience in pharmaceutical Regulatory Affairs, experience with small molecules preferred.
• Required: Experience in cardiology preferred but not required.
• Required: Experience in the preparation of regulatory submissions and documents, annual reports, amendments, and supplements for both FDA and other global health authorities.
• Required: 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).
• Required: Proven ability to develop regulatory strategies in collaboration with regulatory and cross-functional team members and determining the optimal way of communicating to global regulatory authorities.
• Required: Management expertise on the timeline and process for submissions.
• Required: Expert knowledge of regulations and guidance affecting routine regulatory activities and specific therapeutic areas and keeps abreast of the regulatory environment.
• Required: In-depth knowledge of overall global drug development.
• Required: Excellent written, interpersonal and communication skills.
• Required: Action oriented and committed to meeting FDA and other regulations while moving projects forward.
• Required: Able to handle changing priorities and multidisciplinary tasks.
• Required: Easily gains trust and support of peers; encourages collaboration.
• Required: Strong project management skills.