Vacancy caducado!
Role:
Regulatory Product Labelling Duration: 11+ MonthsLocation: 3416-Parkway, NJVertical: Life Sciences Regulatory affairs experience in the pharmaceutical, vaccine, or biological products; or related fields. Hiring process: Phone Interview Onboarding process: Paperwork + BGC Note: Virtual Work(100% Remote), Laptop Will Be Provided By Company For Work. Job Description Knowledge of U.S. and EU regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels.Demonstrated knowledge and understanding of company Core Data Sheets (CDS) and the dynamics of Labeling Team purpose and objectives.Consolidate labeling versions and comments from Labeling reviewers and Regulatory Authorities.Edit and format labeling documents- Ensure the document complies with the appropriate template (e.g., QRD, PLR).Prepare comparison tables for labeling team discussions.Manage the document status and notify internal stakeholders of the availability of labeling documents.Finalize documents post QCOrder SPL for USPIs, notify internal stakeholders of its availability (e.g., Regulatory, Drug Listing). Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Proficient in speaking publicly to senior management when required Must be able to construct a Company Response (MAH response) for health authority questions Masters in Life Sciences Understanding of key regulatory and Labeling principles and SOPs 2-5 years’ experience in Regulatory affairs Proven and relevant regulatory affairs experience in the pharmaceutical, vaccine, or biological products; or related fields.Marketing authorization experience.Masters 's/ Bachelor's degree required in science, engineering or related field (advanced degree preferred)