Sr. Director of Global Regulatory Affairs

at Immunovant

(New York, NY or Durham, NC)

JOB SUMMARY:

Immunovant’s mission is to deliver value to patients in the treatment of autoimmune disease and other immunological disorders. The Senior Director will be responsible for leading the development and execution of global regulatory strategies for innovative medicines that address unmet medical needs and bring significant value to patients through rare disease development programs and expedited pathways in support of Immunovant’s strategic objectives. The Senior Director will maintain focus on corporate goals while responding to the needs of project teams in a highly dynamic, fast-moving environment.

Requirements:

  • Preparation, review and submission of high-quality documentation for INDs, CTAs, NDAs, BLAs, MAAs, and related filings to Regulatory Agencies within established timeframes. Responsibilities will include original applications and product maintenance, such as information amendments and annual reports. May require management of external regulatory writing support.
  • Lead the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure regulatory requirements and strategy are understood by project teams.
  • Communicate project updates and risks to senior management and stakeholders across the organization. Tracking regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions. Interact efficiently and independently with consultants.
  • Experience serving as FDA and EMA liaison and provide leadership and support for Regulatory Agency meetings and teleconferences.
  • Lead efficient integration, including organization and compliance check, for documentation related to new product acquisitions and due diligence activities.
  • Maintain up-to-date knowledge on international and domestic regulatory requirements.
  • Initiate and contribute to the development of policies and procedures in alignment with GxPs, Guidance, and corporate objectives.
  • Lead, mentor, and develop direct reports.
  • Preference for individuals who have experience with rare disease development programs and expedited pathways.
  • Preference for individual with biologics experience.


QUALIFICATIONS:

Education:

  • MD, PharmD, or PhD preferred
  • RAC, or education in a regulatory field strongly preferred


Experience (e.g. Jobs, supervisory, industry, international, etc.)

  • 15 years of biopharmaceutical experience, which include at least 10 years of direct experience in Regulatory Affairs and have successfully filed IND and NDA/MAA submissions
  • Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
  • A “Hands-on”, “roll-up-the-sleeves” leader who understands the need for involvement at all levels of activity within a small company environment. Strategic nature balanced with a biotech mindset and attitude that simply gets things done.
  • An innovative individual who is creative and possesses scientific curiosity.
  • Someone with a high sense of urgency and a driver for results.
  • A highly disciplined individual who is excellent at consistently executing key deliverables.
  • Exceptional communication and collaboration skills.
  • An inclusive individual who thrives in a team-oriented environment. Someone who is positive, respectful and encouraging to colleagues.
  • Experience with biologics development programs, from early-stage through commercial. Experience with parenteral products, including devices, is preferred.


Specialized knowledge, Licenses, etc.:

  • Results-oriented individuals with a strong work ethic and ability to complete projects with minimal oversight; track record of successful IND, CTA, NDA, and/or BLA submissions
  • Knowledge of GxP regulations and ICH & FDA Guidances
  • Ability to blend analytical and critical-thinking skills to enable data-driven, strategically oriented review of regulatory documents


Other skills/attributes:

  • Demonstrated alignment with company values and culture
  • Strong tolerance for change and uncertainty as projects evolve
  • Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
  • Daily demonstrates a positive, ‘can do’ and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
  • Ability to multi-task and shift priorities quickly while working under tight deadlines.
  • Skilled in developing collaborative internal and external relationships.
  • Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
  • Excellent communication skills both written and oral
  • Excellent time management skills
This position has been filled.