Regulatory Affairs Associate — Remote, Growth-focused

Jubilant Pharma Limited; Spokane (WA); On-site; USD 44,000 - 59,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

FSA/HSA

Life Insurance

AD&D

Disability insurance

Job summary

Jubilant HollisterStier LLC in Spokane, WA is seeking an Associate to provide foundational regulatory support to project teams by assisting with the preparation, maintenance, and submission of regulatory documentation while developing knowledge of regulatory requirements and internal processes.

Responsibilities include regulatory submissions (CMC), gathering source documents from SMEs, drafting routine rationales, and supporting responses to regulatory agency questions under senior guidance.

Qualifications

• Associate degree; if no degree + 2 years relevant experience.
• Strong verbal and written English communication.
• Experience with regulatory submissions (CMC) is a plus.
• ERP/MRP systems familiarity (SAP preferred).

Responsibilities

• Regulatory Submissions (CMC).
• Assist with preparation, compilation, and filing of regulatory submissions (e.g., Amendments, Annual Reports, DMF updates).
• Gather and organize source documentation from SMEs to support submission readiness.
• Draft routine scientific rationales or technical sections using established templates.
• Support responses to regulatory agency questions.

Skills

Regulatory knowledge

Documentation skills

Cross-functional collaboration

Education

Associate degree

Tools

SAP

Job description

Jubilant HollisterStier LLC in Spokane, WA is seeking an Associate to provide foundational regulatory support to project teams by assisting with the preparation, maintenance, and submission of regulatory documentation while developing knowledge of regulatory requirements and internal processes.

Responsibilities include regulatory submissions (CMC), gathering source documents from SMEs, drafting routine rationales, and supporting responses to regulatory agency questions under senior guidance.