Regulatory Publishing Manager
Benefits
3w PTO
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Job Purpose:
- Manage and independently execute regulatory submission planning, publishing, and lifecycle management.
- Ensure timely, high-quality submissions that meet Health Authority requirements.
Key Responsibilities:
- Format, publish, transmit, and archive Health Authority submission types.
- Serve as subject matter expert for eCTD structure and publishing technologies.
- Identify IT solutions to enhance submission quality and efficiency.
Qualifications:
- Bachelor's degree with nine years of related experience or equivalent.
- Expertise in regulatory publishing and document management systems like Veeva Vault RIM.
Exelixis
Exelixis is a biotech company dedicated to discovering and developing innovative medicines for difficult-to-treat cancers. With over 25 years of experience, they foster a collaborative and inclusive culture focused on making a difference for patients.