Head of Regulatory Affairs and Quality

Summary:

Cadent Therapeutics is seeking a highly-motivated individual who will be responsible for developing and implementing regulatory strategy and operations for upcoming filings with the US Food and Drug Administration. This individual will provide regulatory leadership and a sense of urgency to cross-functional teams and ensure effective alignment with internal colleagues and external collaborators.

Responsibilities:

Regulatory Affairs

  • Develop regulatory development and approval strategies in collaboration with senior management and by analysis of the guidance and assessment of drugs developed for similar indications
  • Manage/lead regulatory activities and resources associated with Cadent’s drug development programs
  • Manage the planning, preparation, submission and maintenance of INDs, IMPDs, NDAs, BLAs, MAAs, Orphan Drug Applications and other regulatory submissions as appropriate
  • Continually monitor newly published FDA guidelines and international guidance documents with respect to Cadent’s current and future development programs & provide training on applicable requirements for scientific & clinical staff as required
  • Function as the primary liaison with FDA and other regulatory agencies

Quality

  • Plan and oversee internal and external GCP audits
  • Manage/resolve compliance issues for all GxP sites & vendors and provide impact assessment of potential deficiencies to senior management
  • Lead audits for all vendors involved in GxP activities, as necessary
  • Ensure clinical development compliance with all regulations and standards
  • Organize routine auditing activities in support of clinical studies including periodic quality review of trial master files
  • Identify compliance issues and deviations from Health Authority Rules, and Regulations.
  • Improvise the internal quality management system

Qualifications:

  • Requires advanced degree in a science-related discipline or relevant experience demonstrating scientific competence at a similar level (e.g., Ph.D, PharmD, MD)
  • A minimum of 8 years of pharmaceutical industry experience, at least 5 of which should include regulatory responsibilities
  • Thorough knowledge of the drug-development process, with a focus on IND/CTA and NDA/BLA/MAA processes
  • Knowledgeable of GxP environment cGMP, GLP, GCP environments and regulations experience required
  • Knowledgeable of US standards 21CFR210, 21CFR211, 21CFR11 and ICH Quality Guidelines
  • Experience in a functional domain such as discovery, clinical operations, CMC, or another area of drug development highly desired
  • Experience with Central Nervous System (CNS) products highly desired
  • Must possess excellent written and verbal communication skills

When applying, please include the title of the position in the subject line of your email when sending resume to: Careers@cadenttx.com

To apply for this job email your details to careers@cadenttx.com

To apply for this job email your details to careers@cadenttx.com