What are the responsibilities and job description for the Director, Regulatory Affairs position at Priovant Therapeutics?
Overview
Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Director, Regulatory Affairs will be the regulatory lead for specific assigned programs, developing and executing the regulatory strategy for the programs in consultation with the SVP, Regulatory Affairs. S/he will work closely with other functional area and subject matter experts and regulatory operations to execute all regulatory activities.
Responsibilities
Priovant is committed to developing therapies that address high unmet need in autoimmune disease. The Director, Regulatory Affairs will be the regulatory lead for specific assigned programs, developing and executing the regulatory strategy for the programs in consultation with the SVP, Regulatory Affairs. S/he will work closely with other functional area and subject matter experts and regulatory operations to execute all regulatory activities.
Responsibilities
- In consultation with the SVP, Regulatory Affairs, develop the regulatory strategy for assigned programs at all stages of development, in collaboration with cross-functional team members.
- Function as the regulatory point of contact for the program team and as the regulatory liaison to the FDA.
- Execute the regulatory strategy for the program, which may include pre-IND, EOP1, EOP2, IND, CTA, IMPD, NDA, orphan designations, fast track, and breakthrough designation filings.
- Ensure all regulatory commitments and requirements are fulfilled on time and accurately, including but not limited to annual reports, DSURs, and clinical trial registries.
- Plan, prepare for, and help lead regulatory agency meetings.
- Work closely with consultants to ensure regulatory infrastructure is always current, up to date and inspection ready.
- Keep up to date on changing regulatory landscape.
- 8 years of pharmaceutical industry experience, with 6 years in regulatory affairs, including experience at a small/mid-sized biotech.
- PhD, MD, PharmD or other advanced scientific degree preferred.
- Must have prepared for and led regulatory agency meetings.
- Must have successfully developed and completed pre-IND and IND submissions activities. Preferred if also developed and completed NDA/BLA submissions and post-approval activities.
- Must have novel small molecule experience.
- Must have global regulatory clinical trial experience, including EU CTR.
- Experience with later stage and pivotal registration studies preferred.
- Solution-oriented, highly collaborative team player.
- Excellent verbal and written communication skills.
- Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in a rapidly growing company.
- Proven ability to manage multiple projects.
