Regulatory Affairs Consultant

Direct message the job poster from Barrington James

Seeking a Regulatory Affairs Contractor (Associate Director, Global Regulatory Affairs) based along the East Coast. In this role, you will contribute to the development and execution of regulatory strategy, support global submissions, and ensure compliance across all phases of drug development. This position requires strong collaboration with cross-functional teams and regulatory authorities, with a focus on advancing new drug development and commercialization.

Key Responsibilities:

• Lead and implement regulatory strategy for assigned projects across all development phases.
• Prepare and manage INDs, CTAs, NDAs, MAAs, and related submissions.
• Collaborate with partners to align submission timelines and risk mitigation plans.
• Represent the company in meetings with regulatory agencies.
• Interpret scientific data in support of regulatory requirements and strategy.
• Provide leadership and guidance to cross-functional teams and global regulatory project teams.
• Support development of GRA processes and systems to improve efficiency.

Qualifications:

• Bachelor’s degree in a scientific discipline (advanced degree preferred).
• 6+ years of Regulatory Affairs experience in drug development and registration (small molecule or biologics).
• Proven track record with global submissions (EU, international markets).
• Rare disease and pediatric drug development experience strongly preferred.
• Excellent communication, teamwork, and leadership skills.
• Strong project management and computer skills.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Contract

Job function

• Job function

  Project Management, Research, and Strategy/Planning

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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