Director Of Regulatory Affairs

Position Summary: The Director/Senior Director of regulatory strategy will be the regulatory lead for specific assigned programs within My client Sciences and associated “Products”. This position in consultation and alignment with the VP of regulatory affairs is accountable for developing and executing the regulatory strategy for the program. S/he will work closely with the functional area subject matter experts, regulatory CMC lead and regulatory operations to execute all regulatory activities. The role will require direct hands-on contributions, as well as oversight of the growth and supervision of the more junior level regulatory associates. S/he will be a senior member of the My client regulatory leadership team. A successful candidate must have significant experience in early phase of drug development. Experience in late phase development and both small molecule and biologics is strongly preferred. Global experience (EU, ROW, and/or US) is required. Must have led regulatory agency meetings.

Key Responsibilities:

• Leads and mentors junior level regulatory associates.
• Plans, prepares and leads regulatory agency meetings.
• Responsible for executing the regulatory strategy for the program, which may include preIND, EOP1, EOP2, IND, EU CTR, CTA, IMPD, NDA, BLA, orphan designations, PIP/PSP, fast track designation, PRIME, and breakthrough designation filings.
• In consultation with the VP of regulatory affairs, develop the regulatory strategy for assigned projects at early stages of development, in collaboration with cross-functional members
• Responsible and accountable for insuring all regulatory commitments are fulfilled on time and accurately, including but not limited to annual reports, DSURs, PSURs, safety submissions, PMRs, etc.
• Handle in licensing due diligence
• Works closely with operations team to insure regulatory infrastructure is always current, up to date and inspection ready.
• Functions as the regulatory point of contact both for the project team and within the US as the regulatory liaison to the FDA, if US based. If not US based, will work with US agent.
• Provides regulatory assessment and gap analysis for due diligence activities.
• Works with regulatory CMC and operations and functional area subject matter experts to execute the regulatory strategy.
• Therapeutic area experience in oncology, gastroenterology, rheumatology, and infectious disease is preferred.

Skills, Qualifications & Requirements:

• Global regulatory clinical trial experience is essential. This needs to include first in man studies. Preferred if experience also includes later stage and pivotal registration studies.
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
• 10+ years of pharmaceutical industry experience with 7+ years in regulatory affairs
• Must be able to command respect from peers and capable of highly independent work as well as being a team player and role model.
• Must be a highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
• Experience working with the FDA and/or EMA is required. Additional experience with ex-US/ex-EU is preferred.
• Must be solution oriented.
• PhD, MD, PharmD or advanced scientific degree is preferred.
• Must have prepared for and led regulatory agency meetings
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
• Must have either novel small molecule or biologics experience. Preferred if has experience in both. Experience in advanced therapeutics (i.e. gene therapy) is optional.
• Have successfully developed and completed preIND and IND or CTA submissions activities. Preferred if also developed and completed NDA/BLA/MAA submissions and post-approval activities.