REGULATORY AFFAIRS SPECIALIST - REMOTE

Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries.

The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma.

Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products.

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 Regulatory Affairs Specialist position provides regulatory input and guidance for multiple activities supporting JHS products, facility and contracts.

This support ensures that these activities are in compliance with US and International requirements as defined by regulations and standards.

Responsibilities may include participation on project teams, preparation of submissions and post-marketing support of regulatory filings, pharmacovigilance activities, implementation of regulatory strategies and interaction with governmental agencies.

Essential responsibilities include :

• Regulatory Affairs Project Support
• Interacts with multidisciplinary departments, project team members and / or contract clients.
• Prepares and assembles CMC documentation to support regulatory submissions.
• 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.
• Regulatory Global CMC Submission and Compliance
• Assures operation design, processes and 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.
• 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.
• Ensure regulatory compliance for promotional / advertising material.
• Responsible for maintenance activities, which may include, but are not limited to : 1. Master File Annual Updates, 2. Device History File Updates, 3.

Distribution Reports, 4. Drug / Device Listing Reports, 5. License Renewals 6. Annual Registrations and 7. Annual Product Reviews

• Interfaces with Regulatory agencies involving formal and informal meeting discussions under guidance from management.
• Supports the conduct of client audits and agency inspections.

Qualifications :

• Education Required :
• Bachelor's degree or AA degree +5 years of combined experience can be used in lieu of a Bachelor's degree. No degree + 7 years of combined experience can be used in lieu of a Bachelor's degree.
• Experience Required :
• 3 years. Combined experience (e.g., RA, QA / QC, Manufacturing, etc.) within a pharmaceutical, device or other regulated industry.

Regulatory and / or pharmacovigilance experience preferred

• Position requires excellent organizational, technical writing and verbal communication skills.
• Microsoft Word, Excel and PowerPoint required.
• Demonstrated use of electronic systems such as : EDMS, ECMS, ERP / MRP system, eCTD software and / or SP software desired.
• 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.
• Position requires a knowledge of US and International Pharmaceutical and / or Medical Device regulations.
• Interpersonal skills must include clear and concise verbal and written communication of regulatory or compliance position to JHS staff, government agencies, consultants, and contract clients as defined by Regulatory management.
• Must demonstrate a collaborative work style, with a strong ability to build relationships, gain credibility and partner with internal / external customers and co-workers.
• As a product / project participant, the individual is expected to know how to research internal and external sources for solutions and propose guidance in the regulatory aspects of the product assignments.

Shift : Day

Compensation :

The salary range for this position is $67,725 - $104,500 depending on experience.

Benefits :

• 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

Optional Benefits :

• Voluntary Life and AD&D for employee & family
• Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
• Pet Insurance
• ID Theft Protection
• Perk Spot Discount 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 :

[email protected]