Regulatory Labeling Specialist in Mansfield, MA at APEX Systems

Date Posted: 11/7/2019

Job Snapshot

Job Description

Job #:  995240

 
Role: Regulatory Rebranding Specialist
Please apply directly AND send resumes directly to jedaniel@apexsystems.com

Responsibilities: 
  • 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

Qualifications: 
  • Bachelor’s degree required 
  • Regulatory background, labeling experience desired
  • 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
  • Must be deadline conscious
  • Experience within medical device, pharmaceutical or healthcare is a plus
  • Detail oriented is a requirement

 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.