Senior Manager, Regulatory Affairs Labeling

Posted 09 June 2020
Salary Up to US$1 per annum
Location
Job type Permanent
ReferenceBBBH102216_1591740130
Contact NameBria Gaber

Job description

Senior Manager, Regulatory Labeling

Pennsylvania - United States

Seeking a Global Regulatory Labeling Senior Manager to provide regulatory leadership and labeling expertise of new and existing products is successfully maintained globally. This person will be responsible for ensuring all regulatory labeling activities are completed, maintained, and support all labeling requirements. This position will interact with Regulatory Affairs Executives internally and cross-functionally with members US and worldwide Labeling Operations to ensure all labeling objectives and timelines are met successfully.

Responsibilities:

  • Maintain expertise and keep updated with all key labeling guidelines worldwide and regulations as they pertain to the development and maintenance of US and global labeling
  • Provide project management to the Labeling Team throughout the entire labeling process simultaneously making sure all labeling documents are meeting all timelines according to SOPs and external regulatory requirements
  • Plan, prepare and deliver high-quality regulatory files supporting submissions
  • Guide, develop and maintain Core Data Sheets (CDS) and all associated Patient Labeling Documents.
  • Collaborate with RA Compliance and Labelling Compliance & Operations to support continuous improvement of labelling process.
  • Develop responses to Regulatory Authorities with Regional Regulatory Affairs support and key stakeholders
  • Strong proficiency with labeling documents: CCDS, USPI, SmPC, PIL, etc.
  • Drive labeling strategy/meetings by guiding and advising the Labeling Team on internal labeling guidance and policies and will raise awareness of important factors to consider when revising the label.
  • Provides information to Global Labeling Compliance, as required, to support internal and external (i.e. Regulatory Authority) requirements and support audits/inspections as a labeling subject matter expert
  • Remains current with global standards, initiatives by regulatory authorities related to the CCDS and labeling and assures that company processes conform to regulatory requirements.

Qualifications

  • B.S. degree with at least 5 years of experience within the pharmaceutical industry
  • At least 4 years of experience within global regulatory labeling
  • Strong knowledge of global standards and regulations related to CCDS and Product Labeling US PI and EU SmPC experienced required
  • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  • Demonstrates problem-solving ability with ability to analyze risk and make appropriate recommendations and decisions.
  • Must work well with others and within global teams.

If interested in learning more, please contact Bria Gaber at (646) 430-1191 or bria.gaber@investigo-us.com.