Senior Regulatory Affairs Consultant
2 weeks ago
Overview: JCW Group is conducting a search for a Regulatory Affairs Specialist III for a prominent global Biotech firm that is expanding its team. This position is pivotal in orchestrating, overseeing, and documenting regulatory submissions essential for the development of biological therapies.
Work Environment: 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 and ensuring submissions are timely and of high quality.
- 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.
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California, United States JCW Group Full timeJCW Group is conducting a search for a Regulatory Affairs Specialist III to join a prominent global Biotech organization that is expanding its dynamic 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...
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