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Regulatory Affairs Executive

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 as a leader in regulatory projects across various development phases. This position is essential for guiding drug development initiatives and leveraging extensive regulatory knowledge to support project teams in navigating complex requirements, ultimately ensuring successful global development strategies.

Key Responsibilities:

  • Oversees the comprehensive planning, preparation, and submission of intricate regulatory documents to meet project objectives.
  • Directs the creation of high-quality meeting materials, steering meeting strategies and team readiness.
  • Contributes to policy formulation and the international standardization of operational processes.
  • Maintains up-to-date knowledge of regulatory requirements and guidelines in the US, EU, and ICH, proactively communicating any 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 assigned drug development projects, advising teams on regulatory necessities to facilitate successful global strategies.
  • Leads interdisciplinary teams to produce high-quality submissions, including INDs, NDAs/BLAs, meeting requests, and orphan applications, while providing strategic guidance and mentorship to team members.
  • Serves as the main point of contact with Health Authorities for designated products.
  • Engages in negotiations with Health Authorities and assists in interpreting their feedback.
  • Fosters relationships with both internal and external stakeholders, integrating regulatory and drug development expertise to enhance collaboration and achieve organizational goals.

Qualifications:

  • A Bachelor's degree in life sciences is required; an advanced degree is preferred.
  • A minimum of 8 years of relevant experience in regulatory affairs is essential.
  • Experience with NDA/BLA submissions is required.
  • Proven track record in developing regulatory strategies for products targeting chronic and severe life-threatening diseases.
  • Familiarity with document management systems and RIMS is advantageous.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
  • Possesses strategic thinking abilities, capable of interpreting complex regulations and applying them throughout the product development lifecycle.
  • Demonstrates strong analytical and problem-solving skills.
  • Excellent verbal and written communication skills are a must, with the ability to effectively engage with Health Authorities and diverse peer groups.
  • Capability to negotiate innovative development and registration pathways for rare diseases.
  • Proven ability to thrive in a dynamic and culturally diverse environment, both remotely and in person.
  • Experience in crafting global regulatory strategies for products aimed at chronic and severe life-threatening conditions.
  • Willingness to attend meetings and relevant professional conferences as needed, with potential travel requirements up to 15% of the time, subject to business needs.