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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:

1. Regulatory Affairs Project Support
   1. Interacts with multidisciplinary departments, project team members and/or contract clients.
   2. Prepares and assembles CMC documentation to support regulatory submissions.
   3. Provides Regulatory input and guidance based on technical understanding of the manufacturing process, qualifications and reporting requirements.
   4. Participates in discussion of timelines, expectations and possible alternatives to achieve enhanced solutions, when applicable.
2. Regulatory Global CMC Submission and Compliance
   1. Assures operation design, processes and product specifications meet established company and regulatory body requirements.
   2. Compiles, coordinates and generates technical CMC documentation to support submissions in accordance with regulations and relevant guidelines.
   3. Review and approves proposed labeling for compliance with applicable US and International regulations.
3. Post Marketing Support of Regulatory Filings
   1. Maintains approved applications through amendments, supplements and annual reporting such as annual product reviews.
   2. Reviews and approves product and manufacturing changes for license impact and compliance with applicable federal and state regulations.
   3. Performs pharmacovigilance activities.
   4. Ensure regulatory compliance for promotional/advertising material.
   5. Responsible for maintenance activities, which may include, but are not limited to: 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
4. Interfaces with Regulatory agencies involving formal and informal meeting discussions under guidance from management.
5. 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