Associate Director of Regulatory Affairs

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Company: Katalyst HealthCares and Life Sciences

Location: Oakland, CA 94601

Description:

Responsibilities:
  • The ideal candidate will have a strong background in regulatory submissions, project management, and cross-functional collaboration within the life sciences industry.
  • Regulatory Strategy and Submissions.
  • Develop and execute regulatory strategies to support clinical development and product approval.
  • Prepare, review, and submit regulatory filings, including INDs, NDAs, BLAs, PMAs, and other clinical regulatory documentation.
  • Ensure compliance with global regulatory requirements and maintain up-to-date knowledge of relevant regulatory guidelines.
  • Lead cross-functional project teams, providing regulatory guidance and strategic direction to support go-to-market initiatives.
  • Collaborate with R&D, clinical operations, quality assurance, and marketing teams to ensure alignment with regulatory goals.
  • Monitor project milestones and timelines, addressing potential regulatory hurdles proactively.
  • Serve as the primary point of contact with regulatory agencies, facilitating communications, meetings, and negotiations.
  • Communicate regulatory requirements and updates to internal stakeholders, fostering a clear understanding of expectations.
  • Identify and assess regulatory risks associated with clinical and go-to-market projects
  • Develop mitigation strategies to address potential challenges and ensure smooth progression through regulatory pathways.
  • Provide mentorship and guidance to junior regulatory team members, fostering professional growth and knowledge sharing.
  • Contribute to the development of departmental processes, tools, and best practices to enhance operational efficiency.
  • s an Associate Director of Regulatory Affairs, you will have the chance to lead impactful projects, engage with global regulatory agencies, and contribute to improving patient outcomes through innovation.
Requirements:
  • 8+ years of experience in regulatory affairs within the life sciences industry, with a focus on clinical regulatory filings.
  • Proven track record of successful submissions and interactions with regulatory agencies (e.g., FDA, EMA, etc.).
  • Strong understanding of global regulatory requirements, including ICH guidelines and GCP standards.
  • Excellent project management and leadership skills, with the ability to influence and drive cross-functional teams.
  • Exceptional written and verbal communication skills.

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