Regulatory Affairs Executive

2 weeks 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 can effectively guide drug development initiatives by leveraging extensive expertise in regulatory frameworks.

Key Responsibilities:

  • Oversees the planning, preparation, and submission of intricate regulatory documents to align with project objectives.
  • Directs the creation of comprehensive meeting packages and steers meeting strategies to ensure effective team readiness.
  • Contributes to policy formulation and the internationalization of operational processes.
  • Maintains up-to-date knowledge of regulatory requirements 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 programs, advising project teams on regulatory necessities to enhance global development strategies.
  • Leads cross-functional teams to produce high-quality submissions, including INDs, NDAs/BLAs, meeting requests, and orphan applications, while providing strategic guidance and mentoring to team members.
  • Serves as the primary contact with Health Authorities for specific products.
  • Facilitates negotiations with Health Authorities and aids in interpreting their feedback.
  • Builds and nurtures relationships with both internal and external stakeholders, integrating regulatory and drug development insights to promote effective 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.
  • Experience with NDA/BLA submissions is essential.
  • Proven track record in developing regulatory strategies for products aimed at treating chronic and severe life-threatening diseases.
  • Familiarity with document management systems and RIMS.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
  • Strategic thinker with the ability to interpret complex regulations and apply them 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.
  • Capability to negotiate innovative development and registration pathways for rare diseases.
  • Demonstrated success in interacting within a dynamic and culturally diverse work environment, both remotely and in person.
  • Ability to formulate global regulatory strategies for products intended for chronic and severe life-threatening conditions.
  • Willingness to attend meetings and relevant professional conferences as required, with potential travel of up to 15% based on business needs.

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