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Katalyst HealthCares & Life Sciences
Regulatory Affairs Consultant.Katalyst HealthCares & Life Sciences • San Francisco, CA
Regulatory Affairs Consultant.

Regulatory Affairs Consultant.

Katalyst HealthCares & Life Sciences • San Francisco, CA
30+ days ago
Job type
  • Full-time
Job description

Responsibilities:
  • We're looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function.
  • You will work collaboratively with other functional leaders across the organization, as well as external stakeholders.
  • Our ideal candidate will have experience leading the regulatory function in different therapeutics areas and includes both tactical and strategic responsibilities.
  • Work with the team to compile submissions of original IND and responses to all regulatory authority queries.
  • Plan, oversee and participate in all regulatory activities, including regulatory submissions (INDs, NDAs, MAAs, CTAs etc.), internal preparation and agency meetings.
  • Serve as a company contact with the FDA and other regulatory authorities.
  • Ensure all external data complies with required specifications, standards, protocols, SOPs and overall clinical objectives.
  • Enable creative solutions to regulatory challenges to timely advance therapeutics to meet key development milestones including positioning for successful pivotal trials and registration.
Requirements:
  • + years of industry experience in running global clinical regulatory operations and related activities in addition to successful track record as a regulatory consultant required.
  • Excellent working knowledge of regulatory regulations, guidelines, and all phases of clinical drug development.
  • Experience with Type D meetings and responses needed.
  • Ability to lead and advise under pressure, respond to complex operational challenges with innovative solutions supported by appropriate tactics.
  • Ability to occasionally work onsite from our San Diego offices.

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Regulatory Affairs Consultant. • San Francisco, CA

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