Alder BioPharmaceuticals, Inc., is seeking a Senior Manager, Quality Systems, whose primary responsibilities will be the development, implementation and maintenance of commercial quality assurance systems and the inspection readiness program at Alder BioPharmaceuticals and its contract vendors. This role will report directly to the Senior Director, QA Compliance.
The Vice President of Regulatory Affairs will be responsible for developing and leading all regulatory strategies and activities for the organization, including all regulatory submissions. This includes ensuring that all corporate regulatory goals are met, and in compliance with all current industry standards globally. This role will have oversight for an internal Regulatory team, be a key member of the development leadership team at Alder, and will report directly to the Chief Medical Officer.
The Director of Regulatory Affairs will oversee and direct the development and implementation of regulatory strategies for Alder Biopharmaceuticals development programs. Individual will also be responsible for preparation and submission of regulatory documentation to health authorities and direct interaction with regulatory authorities. The incumbent will ensure that all necessary applications are filed and will represent Alder with government agencies.