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Quality & Regulatory Specialist
Ref No.: 18-04353
Location: Mansfield, Massachusetts
Regulatory Rebranding Specialist
Regulatory Affairs
Patient Recovery Rebranding

Contract
Location of Assignment (address): 15 Hampshire Street, Mansfield, MA 02048
Total Weekly Hours: 40
Shift: 1st

Description of Work:
• Participate in cross-functional teams supporting label rebranding
• Partnering with Regulatory Product Specialists, provide regulatory assessment of change on label changes
• Support the Change Development Process through planning, review, execution, and approval of label changes
• Review and approve label artwork changes for compliance with global labeling regulations and product filings
• In collaboration with International Regulatory Affairs, determine applicable registration requirements and assist in preparation of documentation to support re-registration of label changes
• Maintain regulatory systems and produce various reports as needed

Skills/Qualifications:
• Effective project management skills
• Effective oral and written communication skills
• Effective problem-solving skills
• Ability to create cross-functional partnerships
• Ability to work collaboratively in a team environment
• Strong organizational skills
• Deadline conscious
• Regulatory affairs experience is a plus but not required
• Experience within medical device, pharmaceutical or healthcare is a plus
• Detail oriented is a requirement
• Bachelor’s degree required