Job Description SummaryThe Regulatory Affairs Labeling Senior Associate is a key member of the Regulatory Affairs Labeling team and will report directly to the Regulatory Affairs Labeling Director. The Regulatory Labeling Senior Associate will be responsible for the review and approval of all Regulatory Labeling text documentation for Labeling Updates (SLC, RLD, FDA Letters) for all Endo sites. The Regulatory Labeling Senior Associate will be expected to work in an environment that requires strict adherence to procedures necessary to ensure error-free labeling and FDA submissions.
Job DescriptionResponsibilitiesBusiness
- Coordinate all labeling development, reviews, and approvals through the RA labeling group.
- Proofread and review in-house and vendor proofs for labeling components for all Par sites, Third Party and special projects.
- Review of regulatory documentation pertaining to NDA, ANDA and post approval submissions for labeling revision verification.
- Review the Labeling section of NDA and ANDA Annual Reports.
- Review all Brand and Generic Structured Product Labeling (SPL) documents for each Regulatory Labeling Submission.
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50 %
Organization and Support
- Prioritize workflow to meet critical timelines which are consistent with departmental and company objectives.
- Work closely with the Graphics Department regarding all in-house artwork.
- Monitor graphic development of relative labeling components for all generic products.
- Provide support to internal departments, customers and vendors pertaining to labeling requests, inquiries, issues and responses.
- Support implementation and use of documentation systems/tools, e.g. Docuproof.
35 %
Customer Focus
- Work with cross functional team members both within Endo and with Partner Companies
15 %
QualificationsEducation & Experience
- Minimum Bachelor's degree or equivalent experience.
- Minimum of -4-6 years of labeling experience in the pharmaceutical industry.
- Broad based pharmaceutical industry knowledge (Regulatory, Manufacturing, Quality Assurance, Supply Chain, Marketing)
Knowledge
- Strong knowledge of regulations/guidelines governing labeling of pharmaceutical products is required, for both brand and generic drugs.
- Working knowledge of FDA electronic submission documents required.
- Strong knowledge and understanding of current Good Manufacturing Practices and Standard Operation Procedures.
- Experience using an electronic document management system (e.g. Veeva Vault) is required.
- Experience with developing structured product labeling (SPL) and using SPL software is required.
- Experience using an electronic labeling management system is preferred.
Skills & Abilities
- Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules their tasks; Develops realistic action plans.
- Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules their tasks; Develops realistic action plans.
- Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
- Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
