Manager, Regulatory Affairs coordinating global regulatory submissions for therapeutic development. Collaborating cross - functionally to meet regulatory agency requirements and ensure compliance.
About the role
- Senior Scientist responsible for developing and maintaining Core Labeling for pharmaceutical products. Collaborating with global teams to ensure compliance with regulatory requirements and quality standards.
Responsibilities
- developing, maintaining, and implementing Core Labeling for assigned products in line with internal standards and guidelines
- developing, maintaining, and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines
- assisting with developing and maintaining Local Labeling (EU and most of world) for assigned products
- providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements
- serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams
- leading cross-functional teams to develop, review and approve Core and Local Labeling documents
Requirements
- Bachelor’s degree in a scientific or medically related discipline
- Minimum of 3 years of labeling experience or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance)
- Experience in leading cross-functional labeling team (including senior management)
- Ability to assimilate clinical and scientific information, labeling precedent and competitor labeling, and present it concisely
- Understanding of medical concepts and terminology
- Project management skills with the ability to handle multiple projects and prioritize work accordingly
- Proactive problem-solving ability with the ability to make appropriate recommendations/decisions
- Attention to detail and accuracy
- Ability to influence and negotiate
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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