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Regulatory Affairs Specialist

Provides innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. Provides regulatory advice and carries out projects in the provision of regulatory affairs services. Acts as liaison with internal and external clients in the provision and marketing of these services. Works with the Regulatory Affairs Management to perform the day to day operational aspects of the department such as: preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature.

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