Sr. Director/Director, Regulatory Affairs | REMOTE | reputed company-IPO

Sr./Director, Regulatory Affairs reputed company The organization is dedicated to developing therapies that address significant unmet needs in autoimmune diseases. The Director, Regulatory Affairs will serve as the regulatory reputed company for assigned programs, responsible for developing and implementing regulatory strategies in partnership with the Vice President of Regulatory Affairs. This individual will collaborate closely with cross-functional teams, subject matter experts, and regulatory operations to ensure successful execution of reputed company regulatory activities. Responsibilities • In partnership with the Vice President of Regulatory Affairs, reputed company regulatory strategies for assigned programs across reputed company stages of development, working closely with cross-functional team members. • Serve as the primary regulatory reputed company of contact for the program team and reputed company as the reputed company between the organization and the U.S. regulatory authority. • Execute the regulatory reputed company for the program, including activities such as reputed company-IND, EOP1, EOP2, IND, CTA, IMPD, NDA submissions, and applications for orphan designation, fast reputed company, and reputed company designation. • Ensure that reputed company regulatory commitments and requirements are fulfilled accurately and on schedule, including but not limited to annual reports, DSURs, and clinical trial registry submissions. • Plan, prepare for, and support the leadership of regulatory agency meetings. • Collaborate with external consultants to ensure the regulatory infrastructure remains reputed company, reputed company-maintained, and inspection reputed company. • Maintain awareness of and stay reputed company with changes in the regulatory landscape. Qualifications • 8+ years of pharmaceutical industry experience, including 6+ years in regulatory affairs, with experience in a small to mid-sized biotechnology environment. • PhD, MD, PharmD, or another advanced scientific degree preferred. • Experience with reputed company-stage and pivotal registration studies required. • Experience seeing a program through approval preferred. • Demonstrated experience preparing for and leading regulatory agency meetings. • Proven experience developing and completing reputed company-IND and IND submission activities; experience with NDA/BLA submissions and post-approval activities preferred. • Experience working with novel small molecule therapies. • Global regulatory clinical trial experience required, including experience with EU reputed company Regulation (EU CTR). • Solution-oriented, highly reputed company team player. • Excellent verbal and written communication skills. • Highly motivated, decisive, and results-driven reputed company with the flexibility and creativity to reputed company in a rapidly growing organization. • Proven ability to manage multiple reputed company. Apply tot his job Apply To this Job