Senior Pharma Submission SME
Contract Corp To Corp
Contract Independent
Contract W2
24 Months
No Travel Required
On-site
Depends on Experience
Digitech Services
Fitment
Dice Job Match Score™
🤯 Applying directly to the forehead...
Job Details
Skills
- Auditing
- Crystal Management Console
- Pharmaceutics
- Regulatory Compliance
- Regulatory Affairs
- NDA
Summary
Senior Pharma Submission SME for an onsite opportunity in the San Francisco Bay Area, CA.
We''re looking for someone with:
- 10+ years in Regulatory Affairs, Operations, or Technical Writing within biotech/pharma
- Strong expertise in IND, NDA, BLA, eCTD, and global regulatory submissions
- Experience translating technical, clinical, and CMC content into compliant submission packages
- Proven leadership in submission strategy, process optimization, template standardization, and audit/compliance support
- Excellent cross-functional collaboration with scientific, regulatory, and publishing teams
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: 91143714
- Position Id: 9030887
- Posted 2 days ago
Company Info
Our Mission:
To offer an unparalleled customer experience, unleash the creativity of our employees, and generate value for all stakeholders, ultimately benefiting society at large.
Our Vision:
To deliver best-in-class services to clients worldwide seamlessly and to bring joy to every stakeholder involved with us.
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