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Linden, New Jersey
Fort Worth, Texas
Silver Spring, Maryland
Chapel Hill, North Carolina
Hamilton, New Jersey
Little Rock, Arkansas
Location: Philadelphia, Pennsylvania
Type: Full Time
Internal Number: R0014991
The Regulatory Affairs Manager, Americas, Global Business Unit Pharma provides regulatory strategy and technical expertise, to ensure the compliance of Roquette pharmaceutical and nutraceutical products. This includes the development and implementation of regulatory strategies for new products and post-approval maintenance of registered products, in alignment with core business objectives. To decrease and/or minimize all associated costs and risks for the Roquette Group in a preventive, proactive and dynamic manner. This role will report to the Head of Global Regulatory Affairs, GBU Pharma and is based in Philadelphia (hybrid).
Geographical scope: North America & Latin America
Bachelor’s degree in health science, life science, pharmaceutical science or equivalent
Minimum 7 years regulatory affairs experience in US/America region with at least 5 years in pharmaceutical industry. Proven track record of preparation and review of regulatory documentation, and successful management of regulatory file submissions.