What are the responsibilities and job description for the Senior Director of Regulatory Labeling position at Catalyst Life Sciences?
We’re looking for a Senior Director of Regulatory Labeling to join a growing oncology-focused biotechnology firm! This role offers hybrid flexibility (1-3 days/week in-office) in the Boston area.
What you’ll be doing:
- Overseeing creation of labeling documents, including PIs and other documentation, to support clinical pipeline
- Developing and implementing SOPs and and tracking tools/dashboards for creation and maintenance of labeling documents
- Leading the creation of labeling materials, collaborating cross-functionally with other internal stakeholders such as Medical, Marketing, and Legal
What we want from you:
- 8-12 years in Biopharmaceutical regulatory affairs, with recent experience in the Labeling space
- 2-5 years of experience building and leading successful teams
- Bachelor's degree in a Scientific discipline; Master's preferred
- Demonstrated knowledge of US and global regulatory guidelines for labeling materials
If this isn't the right role for you, but you're interested in exploring senior-level opportunities in Regulatory Affairs, feel free to reach out to Hayley at 646-437-7442 or hayley.dylla@catalystcareers.com!