Associate, Reg Affairs

Join a Leader in Pharmaceutical Manufacturing - And Build What's Next

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

For the Builders, Innovators, and Doers - This Is Your Place

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

Why builders choose us:

• 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.

Job Description: Associate, Regulatory Affairs 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. The responsibilities may include the following tasks, knowledge, skills and other characteristics. (This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)

1. 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

1. Operations / Systems

• Support electronic publishing and filing activities following established procedures
• Perform quality checks to ensure documents meet regulatory and company formatting requirements

1. Project Support

• Provide tactical regulatory support to cross-functional teams
• Track deliverables and timelines; escalate risks or delays as identified

1. Technical Guidance

• Develop working knowledge of applicable regulatory requirements and systems
• Seek guidance appropriately and implement feedback into regulatory deliverables

1. 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

1. Strategy Development

• Support implementation of defined regulatory strategies through assigned deliverables

1. Interfacing

• Coordinate requests and information flow with internal teams and approved external partners

External Interfaces:

• Possible Regulatory Agencies (FDA, Health Canada, European Medicines Agency, etc.)
• Print Vendor(s), Translator(s) and Software Vendors

Internal Interfaces:

• Scientific Affairs Team
• Multi-disciplinary Project Teams
• Quality Group (QA, QC, Stability, Records, etc.)
• Manufacturing
• Other(s)

Qualifications:

• Associate's degree OR High School Diploma + 2 years relevant experience required.
• Other languages: French (Canadian) and/or Spanish (desired)
• Position requires excellent verbal and written communication skills in English required.
• ERP/MRP system (SAP preferred)
• Interpersonal skills must include clear and concise verbal and written communication to others within facility. This is extended to external communication with government agencies, consultants, and contract clients as defined by Regulatory management. Position must be able to assist with resolution negotiations that impact Regulatory compliance by creating reasoned and rationale strategies to guide the organization.
• Must demonstrate a collaborative work style, with an ability to build relationships, gain credibility and partner with internal customers and co-workers. Strong organizational and communication skills.
• General Awareness: Knows the fundamental or general understanding of concepts.
• Working Knowledge: Has broad / working knowledge of the subject. Uses concept daily.
• Functional Expert: Candidate is certified functional expert with strong knowledge on concepts.
• Mastery: Candidate is subject matter expert and has command over the subject/ concepts.
• Operates in a routine environment with simple rules and detailed instruction.
• Maintains disciplined, self-motivated remote work practices, ensures timely deliverables, and attends required web-based meetings.
• Manages conflict, influences outcomes, and escalates issues as appropriate.
• Develops an understanding of product and project issues and learns to identify relevant regulations and external guidance. Assists in problem-solving by providing input, drafting recommendations, and supporting proposed actions to address regulatory issues.

Location: Spokane, WA - On Site, Full- -Time

Shift: Days, Monday-Friday 8:00AM-5:00PM

Compensation & Benefits That Start on Day One - Because Your Well Being Matters

Hiring Wage: $64,477.98 - $87,228.27 annually, with opportunities for growth, promotion, and annual raises.

At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.

Starting on your first day, you receive:

• Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program

Unlock Your Potential

If you're seeking a dynamic and rewarding career, we welcome your application today. Apply online:

Careers - Jubilant HollisterStier

Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require assistance applying for a position, contact:
JHS-TalentAcquisition@jubl.com

Our Promise: Caring, Sharing, Growing

We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society.