Specialist, Regulatory Affairs

04 Aug, 2022

Jobs

Specialist, Regulatory Affairs

Jubilant HollisterStier Spokane
Spokane, WA

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.

What can we offer?

A culture that values opportunity for professional growth and development while engaged in the manufacture of life-saving products

Generous paid time off programs in addition to a generous paid holiday schedule

Comprehensive medical, dental, vision, prescription and disability benefit programs starting day 1

Company match for 401k and Roth, 100% vested from day 1

Health and wellness programs, including Employee Assistance Program

Education Assistance Program

The Specialist, Regulatory Affairs 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: 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
  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 or equivalent + 5 years of combined experience (which includes the 3 years in “Experience Required” section) can be used in lieu of a Bachelor’s degree. No degree + 7 years of combined experience (which includes the 3 years in “Experience Required” section) 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.
  • Physical Requirements: Ability to lift 20lbs unassisted desired. Prolonged sitting.
  • Minimal travel (<10%) desired.

Jubilant HollisterStier is a great place to grow!

If you’re up for a rewarding challenge, we invite you to take the first step and apply today!

https://www.jublhs.com/careers/career-opportunities
*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 their protected veteran status and will not be discriminated against on the basis of disability.

If you require assistance applying for a position, please contact our HR Department at:

HResources@jhs.jubl.com

Job posted: 2022-08-04