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Head of Regulatory Strategy

2 months ago

Cambridge, Massachusetts, United States The Steely Group Full time

The Director of Regulatory Affairs at The Steely Group plays a pivotal role as a liaison with Health Authorities and leads regulatory projects across various development phases. This position demands a strategic regulatory leader who will guide drug development initiatives by leveraging extensive expertise to inform project teams on regulatory standards, thereby ensuring effective global development strategies.

Key Responsibilities:

  • Oversees the planning, preparation, and submission of intricate regulatory documents aligned with project objectives.
  • Directs the creation of comprehensive meeting packages, orchestrating meeting strategies and team readiness.
  • Contributes to policy formulation and the internationalization of operational processes.
  • Maintains up-to-date knowledge of regulatory requirements and guidelines in the US, EU, and ICH, proactively assessing and communicating relevant changes within the organization.
  • Stays informed about evolving regulations and health authority actions, applying insights to shape regulatory project strategies.
  • Acts as a strategic regulatory authority for designated drug development initiatives, utilizing deep knowledge to guide project teams on regulatory mandates.
  • Leads cross-functional teams to ensure the delivery of high-quality submissions, including INDs, NDAs/BLAs, meeting requests, and other essential documents, while providing strategic direction and mentorship to team members.
  • Serves as the primary contact with Health Authorities for assigned products, facilitating negotiations and interpreting feedback.
  • Builds and nurtures relationships with both internal and external stakeholders, integrating regulatory and drug development expertise to enhance collaboration and achieve organizational goals.

Qualifications:

  • Bachelor's degree in life sciences; an advanced degree is preferred.
  • A minimum of 8 years of relevant experience in regulatory affairs.
  • Demonstrated experience with NDA/BLA submissions.
  • Proven track record in developing regulatory strategies for products targeting chronic and severe life-threatening conditions.
  • Familiarity with document management systems and regulatory information management systems (RIMS).
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
  • Strategic thinker with the ability to interpret complex regulations and apply them effectively throughout the product development lifecycle.
  • Strong analytical and problem-solving skills.
  • Exceptional communication skills, both verbal and written, with the ability to engage effectively with diverse cultural backgrounds.
  • Capacity to negotiate innovative development and registration pathways for rare diseases.
  • Proven ability to thrive in a dynamic and culturally diverse work environment, both remotely and in person.
  • Willingness to travel up to 15% of the time, as business needs dictate.