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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 leads regulatory projects across various development phases. This position demands a strategic regulatory expert who will guide drug development initiatives, leveraging extensive expertise to inform project teams on compliance requirements and facilitate successful global strategies.

Key Responsibilities:

  • Oversees the planning, preparation, and submission of intricate regulatory documents to meet project objectives.
  • Directs the creation of comprehensive meeting packages, shaping meeting strategies and ensuring team readiness.
  • Contributes to policy formulation and the internationalization of operational processes.
  • Maintains up-to-date knowledge of regulatory standards in the US, EU, and ICH, proactively identifying and communicating changes that may impact the organization.
  • Stays informed about evolving regulations and health authority activities, applying insights to formulate regulatory strategies.
  • Acts as a strategic regulatory authority for designated drug development initiatives, advising teams on compliance to enhance global development outcomes.
  • Leads interdisciplinary teams to produce high-quality submissions, including INDs, NDAs/BLAs, meeting requests, and orphan applications, while providing guidance and fostering professional growth among staff.
  • Serves as the primary contact for Health Authorities regarding assigned products.
  • Engages in negotiations with Health Authorities and assists in interpreting their feedback.
  • Builds and nurtures relationships with both internal and external stakeholders, integrating regulatory and development knowledge to streamline processes 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 aimed at treating 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 verbal and written communication skills, with the ability to engage effectively with Health Authorities and diverse teams.
  • Capability to negotiate innovative development and registration pathways for rare diseases.
  • Demonstrated success in a dynamic and culturally diverse work environment, both remotely and in person.
  • Ability to formulate global regulatory strategies for products targeting chronic and severe diseases.
  • Willingness to attend meetings and relevant professional conferences as needed, with potential travel requirements up to 15% of the time, subject to business needs.