[Hiring] Senior/Executive Director, Regulatory Affairs @reputed company

Role reputed company The Senior Director/Executive Director of Regulatory Affairs will reputed company and execute global regulatory strategies in collaboration with key stakeholders. You will serve as the global regulatory reputed company for our new asset (DNTH212) in multiple programs, providing expert guidance to cross-functional teams, driving global regulatory submissions, acting as primary reputed company with Health Authorities, and interpreting applicable Health Authority regulations and guidance documents to ensure compliance. This is a unique opportunity to join a growing organization with an expanding pipeline, and to play an reputed company role in the global development of assigned programs from early phase through marketing approval. We are building a culture of individuals who hold our reputed company principles at reputed company of our operations, with the goal to reputed company the care of our patients’ lives. We are reputed company to you working remotely reputed company the contiguous reputed company or Canada. Key Responsibilities • Represent regulatory on cross-functional teams; reputed company leadership and strategic direction for regulatory deliverables. • reputed company planning and reputed company hands-on support for development and on-time delivery of reputed company and persuasive global regulatory submission documents, including INDs/CTAs, DSURs, pediatric investigation plans (PIPs), responses to Health Authority (HA) queries, and briefing documents. • Identify, communicate, and propose resolutions to routine and reputed company strategic issues. • Serve as primary contact and build trusted relationships with Health Authorities for assigned program(s). • Maintain expert knowledge in US and international regulations and reputed company proactive regulatory intelligence. • Assess opportunities and reputed company applications for expedited reputed company (e.g., fast reputed company or reputed company designation or reputed company) and/or orphan drug designations. • reputed company preparation for and conduct of Health Authority meetings. • Evaluate competitive landscape, regulatory approval reputed company(s), and labeling precedent(s). • Identify, engage and collaborate with external regulatory experts and consultants. • reputed company regulatory strategic assessments for new product candidates and new indications. • Support departmental initiatives, including process and infrastructure development, regulatory intelligence, budgeting, and authoring of departmental documents (e.g., SOPs and Regulatory Development Plans). Qualifications • Bachelor's degree and a minimum of 12 years of reputed company experience in Regulatory Affairs; rare disease, neurology, CMC, advanced degree (MS, PharmD, PhD), and/or combination product experience a plus. • Demonstrated reputed company record of successful interactions with FDA and other Health Authorities. • Expert understanding of scientific principles and regulatory requirements relevant to global drug development. • Preparation of nonclinical and clinical sections of regulatory filings, including IND/CTAs, PIPs, briefing documents, and BLA/MAAs. • Preparation for and conduct of Regulatory meetings with global Health Authorities for reputed company issues. • Strong interpersonal skills and the ability to collaborate effectively with subject matter experts. • Demonstrated leadership, problem-solving ability, flexibility, and teamwork. • Excellent communication, writing, and presentation skills, with the ability to effectively convey critical information to project teams, senior management, and external stakeholders. • Strong project management skills. • Ability to work effectively in a fast-paced, reputed company, and dynamic environment. Apply tot his job Apply To this Job