Director, Regulatory Affairs Global Labeling

This position is responsible for the development, review, and management of US, EU, and International labeling for commercial products. The manager will ensure labeling strategies are communicated to project teams; labeling is compliant with core labeling and local regulations; labeling is accurate and of high quality; and support implementation of approved labels which may include change management records, document control, QCing documents, translations and verification of translations, and tracking project milestones and status. Preparation of labeling content is based on source documents such as CSRs, regulatory requirements, and other reference documents.

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• Review worldwide labeling against the Core Company Safety Information and facilitate and track implementation of Core Labeling changes.
  
• Assist with the management of CCDSs.
  
• Document control and distribution of product labels including drafting initial documents, annotations, generate and review of SPL files, and prepare final labeling.
  
• Project management role of logistical activities and delivering labeling documents within agreed timeframes.
  
• Facilitate the review and approval process within the product labeling teams, including outlining the label history and documentation of team decisions.
  
• Provide and maintain background documents outlining the purpose and justifications for labeling changes.
  
• Work collaboratively with members of the Labeling Strategy and Implementation Team and other cross functional departments to resolve issues and drive execution of deliverables.
  
• Ensure content of labeling text is verified and maintain version control.
  
• Manage approved labels in a label management database/corporate system to ensure accurate and up to date labeling is available and accessible at all times.
  
• Maintain knowledge of current rules and regulations governing global labeling activities.
  
• Receive and collate labeling text from labeling team members and manage labeling content and revision control; assess text for compliance with labeling requirements and provide team recommendations on appropriate text for labeling content.
  

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• A degree in life sciences.
  
• External labeling training/certificates.
  
• Substantial bio-pharmaceutical industry experience with a strong track record in Regulatory Affairs. Experience with direct management of labeling projects and related activities is essential.
  
• US and EU labeling experience minimally required; international labeling and core labeling experience highly desired.
  
• Proven experience in providing labeling review teams direction and guidance on labeling content, verbiage, and submission requirements worldwide.
  
• Experience with global labeling processes and review of Company Core Safety Information.
  
• Experience in review process, standards, and industry best practice pertaining to labeling.
  
• Strong scientific background and/or experience to quickly establish therapeutic area working knowledge.
  
• Working knowledge of medical terminology and drug safety.
  
• Experience with SPL and PLR requirements.
  
• Proven project management, leading teams from multiple functional areas.
  
• Experience processing and assessing translations of labeling documents to ensure the content is identical to English approved text.
  
• Must be able to work as a team member and independently.
  
• Strong attention to detail and high quality work.
  
• Experience with MS Word, Adobe Acrobat, Excel, MS Project and other tools used in labeling.
  

All employment offers and resumes are managed through our Human Resources Department. Candidates are presented through this avenue. The Human Resources Department at BioMarin requests that recruiters do not contact BioMarin employees directly to present candidates. Compliance with this request will be a factor in determining future professional relationships with BioMarin. BioMarin will not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of BioMarin.