Regulatory Affairs Specialist - Labeling

Kelly® Science & Clinical is seeking a Regulatory Affairs Specialist - Labeling for our client based in Bridgewater, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Hybrid Schedule

Ideal locations: Rochester, NY. Greenville SC, St Louis MO, Tampa or Clearwater FL

Remote option

Length of assignment – 12 months may extend

Day shift- Monday to Friday must be available to work EASTERN time zone hours

Compensation: $45 - $50/hr DOE

Lead labeling artwork development and revision projects. Coordinate with subject matter experts to ensure all labels are compliant with regulations, guidance, internal quality process, and label control/issuance. Responsible for final product label review and approval within the labeling process. Follow, support and improve processes to ensure label accuracy and timeliness of deliverables. Provide technical expertise, leadership and project coordination. Responsible for post approval lifecycle management of labeling.

CORE SKILLS/ RESPONSIBILITIES

• Excellent communication / interpersonal and writing
• Self-motivated and capable of working with supervision and guidance Knowledge in technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project)
• Detail oriented with the ability to proofread and check documents for accuracy and inconsistencies
• Ability to work and contribute to a team environment
• Ability to understand scientific and regulatory requirements

SPECIFIC SKILLS

• Knowledge of pharmaceutical, consumer or medical device industry product labeling processes for review and obtaining regulatory approvals
• Knowledge of pharmaceutical, consumer or medical device industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization and Operations
• Strong technology skills, especially with Microsoft Office and web-based applications
• Ability to read and comprehend technical information such as regulations and standards
• Ability to critically and efficiently review detailed information to support labeling creation and revision
• Simultaneously manage multiple projects and tasks
• Ensure labeling is compliant per procedures and checklists and all requested changes have been made. CO
• Utilize proofreading tools to complete text review
• Proficient in software tools for the development and revision of Structured Product Labeling
• Minimum Associate degree, Bachelor degree preferred or equivalent
• 0-2 year of Regulatory Affairs experience or relevant experience in a regulated environment

Requirements What happens next

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.

Helping you discover what’s next in your career is what we’re all about.