Regulatory Affairs Consultant

3 weeks ago

Cranbury, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Provides strategic global regulatory guidance to cross-functional project teams responsible for product development.
  • ctively leads the development and implementation of regulatory strategies for assigned programs and ensures cross-functional alignment.
  • Coordinates regulatory activities (CMC, nonclinical, and clinical) to assure timelines and milestones.
  • Supports departmental activities with regards to clinical trial conduct and regulatory submissions.
  • Provides Regulatory Risk Assessment (RRA) during various phases of product development.
  • Monitors current and proposed regulatory and legal issues and ensures that key initiatives are communicated to the stakeholders.
  • Monitors/ensures all aspects of regulatory submissions relevant to assigned projects.
  • Supervises the preparation of regulatory submissions to ensure timely submission and compliance with regulations and guidelines.
  • Reviews and approves (when necessary) documents used in regulatory submissions.
  • Participates in preparing IMPDs to support international CTA submissions.
  • Reviews technical documents (Clinical, Nonclinical, CMC).
  • Provides Regulatory support as a key member of Global Regulatory Project Teams.
  • Leads multidisciplinary team responding to Health Authority questions during the IND and NDA review phases for assigned projects.
  • cts as liaison between Regulatory Affairs and other functional areas, including external contractors (e.g., contract research organization teams and vendors).
  • Maintains knowledge and monitor changes in pertinent laws, regulations, and guidance.
  • Interprets external developments and inform/educate internal stakeholders.
  • Identifies the need for new regulatory processes and SOPs, approves and ensures implementation.
  • Works closely with Regulatory Operations to ensure e-CTD compliance.
Requirements:
  • B.S. degree in a scientific discipline.
  • M.S. or equivalent experience is preferred.
  • Minimum of 7 years of regulatory experience respectively within the pharmaceutical or biotechnology industry.
  • Experience in the development of drugs, biologics/vaccines, and in the rare disease space.
  • Experience designing and executing creative development strategies for NCE and biologics development programs.
  • Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in eCTD format.
  • Experience with international clinical trials and regulatory documentation.
  • Experience in preparation of critical submission documentation.
  • Experience leading multidisciplinary teams.
  • Comprehensive understanding of FDA regulations and ICH guidance, as well as comprehensive experience in the drug development process.
  • Expertise in translating regulatory requirements into practical, workable plans.
  • Willingness to travel as required within a global work environment.

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