Director, Regulatory Affairs

Location
Washington D.C.
Posted
Oct 27, 2021
Required Education
Masters Degree/MBA
Position Type
Full time

BROAD FUNCTION AND SCOPE OF THE POSITION: -Can be hybrid or remote work structure

  • ·Lead and develop JDRF strategy to accelerate regulatory approval of drugs and biologics for priority type 1 diabetes therapies.
  • ·Collaborate with Senior Director, Regulatory Affairs on strategies to advance priority drugs and/or biologics therapies that may also be device combinations.       

 SPECIFIC RESPONSIBILITIES:

  • Develop and implement JDRF strategies to accelerate regulatory approval for priority drugs and biologics, such as beta cell replacement therapies, disease modifying immune therapies, and therapies to improve glucose control and complications associated with type 1 diabetes.
  • Manage planning and engagement with industry partners regarding regulatory processes.
  • Provide strategic assessment and support for JDRF funded academic investigators to ensure success for regulatory submission to conduct research studies
  • Interface directly with regulators as needed
  • Identify needs for outside regulatory advisors and oversee work.
  • Collaborate closely with members of the JDRF scientific, advocacy and communications teams; Ability to assess legislative and regulatory policy proposals and collaborate with internal and external stakeholders to communicate impacts to JDRF mission and develop strategies to mitigate risks and advance research priorities
  • Report on progress and advise JDRF leadership and allies on regulatory issues as needed.

·

EDUCATION:

  •  Advanced scientific, legal, or business degree preferred.

YEARS OF EXPERIENCE:

  • 5-10 years of related experience required.

KNOWLEDGE:

  • Extensive knowledge of FDA drug and biologics regulatory guidance, processes, policy, and officials.  Experience in European or other countries/regions regulatory processes a plus.

OTHER REQUIREMENTS:

  • Experience with developing, implementing, and leading product specific regulatory interactions with US FDA and/or other regulatory bodies for early and/or late clinical stage drug or biologic therapies OR experience developing, implementing, and leading regulatory policy initiatives.
  • Proven track record of success in achieving NDA or BLA approval for complicated medical therapies desired.
  • Self-starter that requires little supervision and can work and make judgments independently. 
  • Effectively multi-task, establish priorities, and work in a fast-paced environment. 
  • Excellent written, oral, and communication skills.
  • Travel (approximately 10%)

Additional information

.To protect the health and safety of our employees, all new hires are required to be fully vaccinated for COVID-19 by September 7, 2021.  The only potential exception to this rule is for applicants who cannot be vaccinated due to a disability or sincerely held religious belief.