Associate Director of Regulatory Affairs and Global Labeling - Pharmaceuticals
Well established industry leader seeks an Associate Director of Regulatory Affairs and Global Labeling to develop and implement regulatory labeling strategy and documentation for products in development.
*** Lead development, review, approval, and implementation process for Core Data Sheets (CDSs), US Package Inserts (PIs), Summary of Product Characteristics (SmPCs), and similar labeling documents.
*** Serve as subject matter expert for key labeling requirements and regulations.
*** Review and approve labels, patient leaflets, cartons, and similar labeling documents.
*** Develop processes to review and approve CDS and country-specific labeling, tracking of CDS updates as part of the signal detection and management process, implementation of CDS in country-specific labeling, and archiving of labeling.
***Bachelors in Health or Life Sciences related field.
***8+ years of Global Labeling experience in Pharmaceutical, Biotechnology, or similar field.
Scientific leadership role offers a competitive compensation package commensurate with experience, bonuses, full medical benefits, 401(k) savings plan, stock options, health and wellness benefits, generous paid vacation time, numerous professional development opportunities, and more!
Please reference #37274218 when responding.Education Requirements: Bachelor DegreeMinimum Experience Requirements: 5-10 yearsJob City Location: BerkeleyJob State Location: CAJob Country Location: USASalary Range: $150,000 to $250,000
WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES: Top 10 Job Site Top 10 Careers Site Director of Global Labeling Global Regulatory Function Label Processing Pharmaceutical Products Regulatory Affairs FDA Quality Assurance Specification Specialist Regulatory and Product Administration Manager Labeling Claims Manager
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