Cytokinetics

Cytokinetics

Associate Director, Regulatory Affairs

South San Francisco, California · Director

Sponsorship not specified$201k-$234kDetected 14 days ago
ComplianceClinical TrialsFDA RegulatoryCommunicationGxPRegulatory Affairs

About the role

  • The position operates in a highly collaborative, fast-paced biotech environment with significant cross-functional engagement.
  • The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
  • Our employees come from different backgrounds, and we celebrate those differences.

Responsibilities

  • Contribute to development and execution of regulatory strategies for assigned programs and serve as regulatory lead for assigned clinical studies
  • Identify potential regulatory risks and develop mitigation approaches
  • Lead preparation, review, and timely submission of high-quality, compliant regulatory documents (INDs, CTAs, amendments; NDAs, supplements) and moderately complex regulatory submissions
  • Proven ability to manage multiple priorities and work effectively across teams, functions and with external partners

Requirements

  • 8+ years of drug development, including 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry
  • Excellent working knowledge of global regulatory requirements (FDA, EMA, ICH), including an understanding of GXP
  • Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus

Nice to have

  • Bachelor's degree is required, preferably in a scientific field
  • advanced degree is a plus

Compensation

  • In the U.S., the hiring pay range for fully qualified candidates is $200,700-$234,150 per year.
  • The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

Benefits

  • Support preparation for health authority interactions, including briefing packages and response documents
  • Experience supporting regulatory submissions (e.g., IND/CTA/eCTD) and health authority interactions

Equal opportunity

  • www.cytokinetics.com
  • Cytokinetics is an Equal Opportunity Employer
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This listing is sourced directly from Cytokinetics's careers page and normalized into a canonical job model.