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Associate Director, Labeling - Regulatory Affairs

Cambridge, Massachusetts

Post Date: 09/12/2017 Job ID: 1565 Job Category: Clinical: Regulatory

Associate Director of Regulatory Affairs Labeling is responsible for providing  regulatory guidance and oversight of US and global labeling activities for assigned products.  This person will report to the Head of Regulatory Affairs and will be responsible for maintaining labeling documents throughout the product lifecycle.   The person assuming this newly created position will have a unique opportunity to build, develop, and update labeling processes, systems and SOPs.

Job Responsibilities:
  • Provide expertise in labeling requirements while staying current in regulations and guidance’ s
  • Manage and improve labeling development process and SOPs for company products
  • Work cross functionally to establish and maintain a core company data sheet for approved products
  • Manage required labeling updates, proofreading, and version control 
  • Manage quality control over entire labeling process
  • Work with the Regulatory Affairs Strategist on planning, managing and implementing labeling updates
  • Work with Regulatory Affairs strategist to research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities.
  • Review Regulatory Target Product Profiles as requested
  • Work with Supply Chain and Regulatory Operations to facilitate conversion of label to structured product labeling (SPL) and updating SPL as needed for CMC and labeling changes
  • Communicate and disseminate newly approved labeling to internal stakeholders
  • Work with corporate partners to obtain current versions of labels for partner-owned products; communicate and manage labeling changes with global partners, as appropriate.
  • Maintain tools that support coordination with other functions (e.g., Marketing) to ensure only agency approved labels are produced for appropriate products
  • Maintain and catalog all labeling materials in accordance with company policies, procedures, and technologies. 

Qualifications/ Requirements:
  • BS degree in life sciences required, Graduate degree in Regulatory or related discipline preferred
  • 9 years of experience in regulatory affairs with focus on labeling for at least 5 years
  • Experience associated with US product labeling regulations required
  • Experience with SPL and PLR format required
  • Thorough understanding of US labeling regulations is required
  • Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
  • Must have a good understanding of the pharmaceutical environment and the ability to work proactively through labeling revisions and the product review process
  • Must have the technical ability to become quickly proficient in the use of controlled regulatory document management systems
  • Global regulatory/ labeling experience - familiarity with labeling regulations in other countries (e.g., EU, Canada, Australia,  Japan) is desired

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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