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Senior Regulatory Affairs Consultant

2 months ago

California, United States JCW Group Full time

JCW Group is conducting a search for a Regulatory Affairs Specialist III to join a leading global Biotech organization that is expanding its team. In this pivotal role, you will be instrumental in orchestrating, overseeing, and monitoring regulatory submissions and documentation essential for the development of biological therapies.

This position is remote; however, candidates must be based in California to facilitate site visits as necessary.

Key Responsibilities:

  • Responsible for the preparation, publication, quality assurance, validation, distribution, and archiving of global regulatory submissions.
  • Engage collaboratively with diverse teams worldwide, including regional Regulatory Affairs Managers and publishing teams.
  • Oversee and inspire project teams, promoting a culture of excellence while ensuring timely and high-quality submissions.
  • Assist in the adoption of innovative technologies, tools, and processes.

Qualifications:

  • Bachelor's degree in life sciences or a related discipline.
  • A minimum of 4 years of experience in Regulatory Affairs within the life sciences sector.
  • Proficient in CTD regulatory submission formats.
  • Experience with DMF is advantageous.