Associate, Regulatory Affairs

Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next

As Spokane’s Largest Manufacturing Company
, Jubilant Hollister Stier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life changing medicines around the world.

We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant Hollister Stier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life changing medicines around the world.

If you are someone who thrives on solving complex problems, improving systems, and building real solutions
, you’ll feel at home here. At Jubilant Hollister Stier, your ideas matter — and your impact is felt globally.

• Immediate impact:
  Your work directly supports essential medicines and allergenic therapies used worldwide.
• Benefits start on day one:
  Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well-being shouldn’t have a waiting period.
• A career you can grow:
  We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.
• A culture of improvement:
  We value people who thrive on continuous improvement, innovation, and hands on contribution.
• A stable industry leader:
  Backed by Jubilant Pharma, we pair long term stability with forward looking innovation.

If you want to build something meaningful with a team that values your drive, skills, and ideas —
you belong here.

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, guidance, and internal processes. The Associate role builds regulatory competency and reliability by executing defined tasks to ensure accuracy, compliance, and timely delivery of regulatory activities.

• 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 with guidance from senior staff.

• Operations / Systems
• Support electronic publishing and filing activities following established procedures
• Perform quality checks to ensure documents meet regulatory and company formatting requirements
• Project Support
• Provide tactical regulatory support to cross-functional teams
• Track deliverables and timelines; escal…
• Technical Guidance
• Develop working knowledge of applicable regulatory requirements and systems
• Seek guidance appropriately and implement feedback into regulatory deliverables
• Compliance
• Support compliance activities, audits, and inspections through document preparation and record maintenance
• Assist in review of change controls and external communications for regulatory accuracy
• Strategy Development
• Support implementation of defined regulatory strategies through assigned deliverables
• Interfacing
• Coordinate requests and information flow with internal teams and approved external partners

Required:

Associate’s degree – If no degree + 2 years relevant experience.

• Other languages:
  French (Canadian) and/or…