About Dermavant:


Dermavant Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies for inflammatory skin diseases and medical dermatologic conditions. We are passionate and dedicated to realizing the full potential of biomedical research and to developing and commercializing novel first-in-class or best-in-class therapies that improve patients’ lives. The patient is at the heart of everything we do.


Position:


The Director will be responsible for leading the development and execution of global regulatory strategies for innovative topical and systemic dermatological medicines that address unmet medical needs and bring significant value to patients. A successful candidate will maintain focus on corporate goals while responding to the needs of cross-functional, matrix project teams in a highly dynamic, fast-moving environment.



Responsibilities:


  • Preparation, review and submission of high-quality documents for INDs, CTAs, NDAs, BLAs, MAAs, and related filings to regulatory agencies around the world within established timeframes; responsibilities will include original applications and product maintenance, such as information amendments and annual reports
  • 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; track regulatory commitments and deliverables while coordinating with internal and external staff to ensure high quality and on time submissions; interact efficiently and independently with consultants
  • Serve as FDA liaison, develop regulatory strategy, successfully prepare teams, and lead 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 of 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



Qualifications:

  • 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
  • BS or MS with at least 7 years of increasing responsibility in regulatory affairs; Advanced degree, RAC, or education in a scientific field strongly preferred



What we look for in our people:

  • Highly motivated self-starter with an entrepreneurial spirit and commitment to personal and career development.
  • Desire to work in a quickly changing and fast-paced growing business.
  • Unrelenting dedication to delivering results and a desire to shape the strategic goals of the business. Willing to roll up your sleeves to get the job done.
  • Ability to overcome ambiguity and challenge the status quo
  • Manage multiple programs with competing and aggressive time lines, prioritize activities, and work independently.
  • Excellent written and oral communication skills; experienced presenter of key messages to broad audiences including Senior Stakeholders

This position has been filled. Would you like to see our other open positions?