[xrecnet] Senior Regulatory Affairs Submission Strategy Lead /// Remote /// Longterm

Hi All,

Please share your candidates profiles to vardhan@tetrahed.com

Job Title: Senior Regulatory Affairs Submission Strategy Lead.

Location: Remote (Should work in PST time zone preferably from the Bay area).

 

Technical Skills:-

• 10+ years of experience in regulatory affairs, operations, or technical writing within the biotech or pharmaceutical industry
• Expertise in regulatory submissions including INDs, NDAs, BLAs, eCTD, and global health authority requirements
• Ability to translate complex technical, clinical, and CMC content into compliant submission formats
• Experience leading submission strategy, process development for authorship, technology leadership, template standardization, process optimization, and audit/compliance support
• Strong collaboration skills across scientific, regulatory, and publishing teams

Thanks,

Vardhan 

Email: vardhan@tetrahed.com

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