Regulatory Affairs Director

1 week ago

San Diego, California, United States Codera Full time
Job Description

Overview

Codera, a leading life sciences-focused investment company, is seeking a highly skilled Regulatory Affairs Director to support the development and execution of domestic and international regulatory strategy.

Key Responsibilities

  • Regulatory Strategy Development: Provide strategic advice and support the development and execution of regulatory strategies and plans to ensure compliance with regulatory requirements.
  • Regulatory Milestone Management: Ensure regulatory milestones are met to support approval strategies and overall business goals of the company.
  • Submission Planning and Review: Plan, prepare, and/or review submissions to regulatory authorities, including FDA, EMA, and other regulatory authorities, to support the conduct of clinical trials and approval of marketing applications.
  • Document Authoring and Review: Plan, author, and/or review nonclinical and clinical study documents, including clinical study protocols, clinical study reports, investigator's brochures, nonclinical and clinical summaries, and scientific publications.
  • CMC Document Management: Plan, author, and/or review chemistry, manufacturing, and controls (CMC) documents, including CMC sections of regulatory applications and supporting records summarizing manufacturing process development and validation.
  • Regulatory Document Verification: Ensure that regulatory documents are accurate, complete, and verifiable and confirm compliance with regulatory requirements and conformance to the company quality standards.
  • Progress Tracking and Communication: Track progress of regulatory deliverables against timelines, proactively communicate progress and issues to key stakeholders, and support development of proactive mitigation plans for identified risks.
  • Collaboration and Vendor Management: Collaborate with vendors who support regulatory operations-related tasks and assist with developing and maintaining regulatory document processing and regulatory submission publishing standards and procedures.
  • Regulatory System Enhancement and Inspection Support: Identify and communicate regulatory system enhancement needs or technical issues and assist with regulatory inspection activities, as necessary.

Qualifications

  • Bachelor's Degree required
  • Master's Degree in a life sciences discipline preferred
  • Minimum 7 years of progressive experience in drug development and regulatory affairs and/or operations required
  • Must have experience with regulatory submission documents, including documents required for IND, CTA, NDA/BLA, MAA, and other related submissions
  • Direct experience in interactions with health authorities and performing country and region-specific submissions
  • Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas
  • Possess a willingness and ability to work hands-on and with a high level of detail-orientation, in a fast-paced, entrepreneurial environment
  • Strategic agility, strong critical and logical thinking with ability to analyze problems
  • Ability to establish and maintain collaborative working relationships with internal and external stakeholders

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