Specialist, Regulatory Affairs

Jubilant HollisterStier LLC, Spokane's Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

Job Description:

The Specialist, Regulatory Affairs provides regulatory input and guidance for multiple activities supporting JHS products, facility and that these activities are in compliance with US and International contracts. This support ensures requirements as defined by regulations and standards. Responsibilities may include participation on project teams, preparation of regulatory filings, pharmacovigilance activities, submissions and post-marketing support implementation of strategies and interaction with governmental regulatory agencies.

1. Regulatory Affairs Project Support

• Interacts with multidisciplinary departments, project team members and/or contract clients.
• Prepares and assembles CMC documentation to support regulatory submissions.
• Follows agency position and company policy.
• Provides Regulatory input and guidance based on technical understanding of the manufacturing process, qualifications and reporting requirements.
• Participates in discussion of timelines, expectations and possible alternatives to achieve enhanced solutions, when applicable.

1. Regulatory Global CMC Submission and Compliance

• Assures operation design, processes and the end product specifications meet established company and regulatory body requirements.
• Compiles, coordinates and generates technical CMC documentation to support submissions in accordance with regulations and relevant guidelines.
• Review and approves proposed labeling for compliance with applicable US and International regulations.

1. Post Marketing Support of Regulatory Filings

• Maintains approved applications through amendments, supplements and annual reporting such as annual product reviews.
• Reviews and approves product and manufacturing changes for license Impact and compliance with applicable federal and state regulations.
• Performs pharmacovigilance activities.

1. Ensure regulatory compliance for promotional material.
2. Interfaces with Regulatory agencies involving formal and informal meeting discussions under guidance from management.
3. Supports the conduct of client audits and agency inspections.

Qualifications:

• Bachelor's degree required
• 2 years of combined experience + AA degree or equivalent can be used in lieu of a Bachelor's degree.
• 4 years of combined experience + no degree can be used in lieu of a

Bachelor's degree.

• 3 years combined experience (e.g., RA, QA/QC, Manufacturing,

etc.) Within a pharmaceutical and/or device industry required.

• Regulatory and/or pharmacovigilance experience preferred
• Position requires excellent organizational, technical

Writing and verbal communication skills.

• Working Knowledge in Microsoft Word, Excel and PowerPoint required.
• Demonstrated use of electronic systems such as:

EDMS, ECMS, ERP/MRP system, eCTD software and/or SP software required

• Position requires the understanding of the products and

Processes and the associated qualification activities

Involved in preparing CMC documentation that support

Both domestic and international applications.

• Prolonged Sitting and repetitive/patterned situations
• Minimal travel (<10%) desired.

Shift: Weekday Days, Monday- Friday

Compensation & Benefits:

This is an on-site, full-time position located in Spokane, WA.

• Hiring Wage: $77,968.80 - $107,700 annually depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role

• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
• Life, AD&D, Short and Long Term Disability
• 401(k) with company match
• Generous paid time off plan
• Employee Assistance Program

Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!

https://jubilantcareer.jubl.com/

*Please click on the Spokane, Wa. Link*

Jubilant HollisterStier is an EEO/AA Employer.

All qualified applicants will receive consideration for employment 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, please contact our HR Department at:

JHS-TalentAcquisition@jubl.com