JCW is working on an exciting search for Regulatory Affairs Specialist III for global Biotech who is expanding their growing team. In this role you will play a key role in planning, managing, and tracking of regulatory submissions and documentation for the production of biological medicines.
This role is remote but you must be located in California to visit their sites when needed.
Responsibilities:
- Accountable for preparing, publishing, quality reviews, validation, dispatch & archiving activities related to global regulatory submissions
- Collaborate globally with various teams, including regional Regulatory Affairs Managers and a publishing teams
- Monitor and motivate project teams, fostering a culture of excellence and ensuring timely and high-quality submissions.
- Support the implementation of new technology, tools, and processes
Qualifications:
- Bachelor's degree in life sciences or a related field
- 4+ years of Regulatory Affairs experience in the life sciences industry
- Familiarity in CTD regulatory submission formats
- DMF experience a plus
For more information please email Megan at megan.moran@jcwresourcing.com
