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Signitives

Veeva RIMS Senior Pharma Submission SME

Pay: $43.86–$52.82/hr

Posted: 5 days ago

Location: Foster City, CA (Hybrid)

Last Updated: 2 days ago

Hours: Full-Time

Expires: 10/15/2026

Career Insights for Pharmaceutical Manufacturing Process Engineer

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What they do

A Pharmaceutical Manufacturing Process Engineer designs and maintains manufacturing equipment, facilities and processes for a pharmaceutical company. Maintains process controls for the specific sterile processing requirements of pharmaceutical manufacturing.

$121,138 / year median in California

+14% projected growth

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Job Description

Veeva RIMS - Senior Pharma Submission SME Signitives Foster City, CA Job Details Contract $43.86 - $52.82 an hour 10 hours ago Qualifications FDA submissions Process improvement Investigational new drug (IND) applications Policy & process development Pharmaceutical company experience Chemistry, manufacturing & controls Communication with regulatory authorities for clinical trials Cross-functional communication

Full Job Description Job Title:

Veeva RIMS -

Senior Pharma Submission SME Experience Required:

10+ years

Location:

Foster City, CA - 4 days onsite/week

Duration:

12 months

Domain:

Pharmaceutical /

Biotech Visa Status:

USC / GC ONLY

Local Requirement:

Must be local to Foster City, CA / Bay Area or nearby cities

Job Overview:

Seeking a senior Pharma Regulatory/Submission SME with strong Veeva RIMS experience and a proven pharmaceutical/biotech background. The consultant will support regulatory submissions, submission strategy, process optimization, authorship standards, technology leadership, and compliance activities.

Key Responsibilities:

Lead regulatory submission strategy and process development. Work extensively with Veeva RIMS for regulatory operations. Support submissions including INDs, NDAs, BLAs, and eCTD . Ensure submissions align with global health authority requirements. Translate complex clinical, technical, and CMC content into compliant submission formats. Develop and standardize submission templates and processes. Drive process optimization and technology improvements. Support audit and regulatory compliance activities. Collaborate with scientific, regulatory, publishing, and cross-functional teams.

Mandatory Skills:

10+ years in regulatory affairs, regulatory operations, or technical writing. Strong Veeva RIMS experience. Pharmaceutical/biotech industry experience. Regulatory submissions experience. INDs, NDAs, BLAs, and eCTD. Global health authority requirements. Regulatory submission strategy/process development. Strong understanding of regulatory operations. Strong cross-functional communication. Good to

Have:

CMC content experience. Submission template standardization. Regulatory technology/process optimization. Audit/compliance support. Technology leadership within regulatory submissions.

Pay:

$43.86 - $52.82 per hour Expected hours: 40.0 per week

Work Location:

Hybrid remote in Foster City, CA 94404