The Specialist, Regulatory Affairs provides regulatory input and guidance for all 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 include participation on project teams, preparation of submissions and post-marketing support of regulatory filings, implementation of regulatory strategies and interaction with governmental agencies.
Regulatory Affairs Project Support
Interacts with multidisciplinary departments, project team members and/or contract clients.
Prepares and assembles CMC documentation to support regulatory submissions.
Represents 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.
Regulatory Global CMC Submission and Compliance
Assures the design, operation of processes and the end product specifications meet the established requirements while ensuring that the processes comply with all regulatory body regulations.
Compiles, coordinates and generates technical CMC documentation to support submissions in accordance with regulations and relevant guidelines.
Prepares agency responses that support pending applications.
Generates regulatory applications using electronic publishing systems when applicable.
Review and approves proposed labeling for compliance with applicable US and International regulations.
Post Marketing Support of Regulatory Filings
Maintains approved applications through supplements and annual reporting such as annual product reviews.
Reviews and approves product and manufacturing changes for compliance with applicable regulations
Implementation of Regulatory Strategy as Directed by Regulatory Management
Ensure regulatory compliance for all promotional/advertising material.
Interfaces with Regulatory agencies involving formal and informal meeting discussions as requested
Supports the conduct of client audits and agency inspections.
Responsible for Maintenance Activities which include, but not limited to: Master File Annual Updates, 2. History File Updates, 3. Distribution Reports, 4. Drug/Device Listing Reports, 5. License Renewals 6. Annual Registrations and 7. Annual Product Reviews
Bachelor of Science required. A major in Microbiology, Chemistry or related scientific discipline preferred. Advanced degree desired.
RAC certification preferred.
Minimum of 3+ years of combined experience within pharmaceutical and/or device industry required.
Must have FDA Regulated Industry experience and experience with ISO or cGMP pharmaceutical manufacturing or related healthcare experience required.
Position requires strong organizational, technical writing and interpersonal communication skills and or Regulatory CMC experience.
Proficiency using Microsoft Word and Excel required. Experience using Microsoft PowerPoint, Microsoft Access, ERP/MRP system, Adobe Acrobat, and/or Complaint Handling database desired.
Knowledge of US and International Pharmaceutical and/or Medical Device regulations, standards, policies and guidance documents required.
This position requires the understanding of the product and processes and the associated qualification activities are essential in preparing CMC documentation that support both domestic and international applications.
Physical Requirements: Ability to lift 20 lbs unassisted, 20/30 corrected near-point vision, and prolonged sitting. Minimal travel required.
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!
http://www.jublhs.com/careers/employment-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:
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
Highly competitive base pay
Comprehensive medical, dental and disability benefits programs
Group retirement savings program
Health and wellness programs