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Director of Regulatory Affairs

3 months ago

Cambridge, United States The Steely Group Full time

This role serves as a Health Authority liaison and Regulatory Project Leader for multiple projects in various stages of development. More specifically, the Director, Regulatory Affairs serves as a strategic regulatory leader for assigned drug development programs and uses extensive knowledge to advise project teams on regulatory requirements to drive successful global development strategies. The Director manages the planning, preparation, and submission of complex regulatory dossiers in support of project goals. She/He also leads cross-functional teams to deliver high-quality submissions, e.g., INDs, NDAs/BLAs, meeting requests and briefing documents, orphan applications, pediatric study plans, etc. and provides strategic direction and mentoring to staff, foster staff engagement and development.


Responsibilities:

  • Manages the planning, preparation, and submission of complex regulatory dossiers in support of project goals.
  • Leads preparation of high-quality meeting packages, drives meeting strategy and team preparation.
  • Contributes to the generation of policies and to the globalization of work processes.
  • Maintains knowledge of US, EU and ICH regulatory requirements and guidelines and anticipates, assesses, and communicates changes in regulatory framework throughout the organization, as relevant.
  • Keeps abreast of changing regulations and health authority actions, applies knowledge to devise regulatory project strategy.
  • Serves as a strategic regulatory leader for assigned drug development programs and uses extensive knowledge to advise project teams on regulatory requirements to drive successful global development strategies.
  • Leads cross-functional teams to deliver high quality submissions, e.g., INDs, NDAs/BLAs, meeting requests and briefing documents, orphan applications, pediatric study plans, etc. and provides strategic direction and mentoring to staff, foster staff engagement and development.
  • Serves as the primary liaison with Health Authorities for assigned products.
  • Negotiates with Health Authorities, aid in the interpretation of Health Authority feedback.
  • Builds relationships with internal and external stakeholders and integrates regulatory and drug development knowledge to facilitate ways of working and achievement of project and company goals.


Requirements/Qualifications:

  • Bachelor’s degree in life sciences, advanced degree preferred.
  • Must possess 8 years of relevant regulatory experience.
  • Must have NDA/BLA experience.
  • Experience developing regulatory strategies for products intended to treat chronic diseases and products intended to treat severe, life-threatening diseases.
  • Experience with document management systems, RIMS
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
  • Strategic thinker, able to interpret complex regulations and apply them appropriately, throughout the product development lifecycle,
  • Ability to quickly integrate information, define and mitigate risk, and prioritize activities among multiple projects.
  • Strong analytical skills and problem-solving capabilities.
  • Must have excellent communication skills (verbal and written). Must be able to effectively communicate with Health Authorities and with peer group members from diverse cultural backgrounds.
  • Ability to negotiate novel development and registration pathways for rare diseases.
  • Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace, remotely and in person.
  • Ability to develop global regulatory strategies for products intended to treat chronic diseases and products intended to treat severe, life-threatening diseases.
  • The incumbent may occasionally attend meetings at company sites, and relevant professional conferences. Travel could be scheduled based upon the needs of the business, up to 15% of the time, barring pandemic restrictions.