Senior Associate, Regulatory Affairs

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Job Description Summary Supports regulatory objectives, advice, and strategy in alignment with department and corporate goals. Coordinates regulatory document preparation for regulatory submissions. Keeps abreast of evolving regulatory procedures and practices. Duties and Responsibilities The Senior Associate/Associate of Regulatory Affairs will be responsible for supporting the coordination and preparation of submission of global regulatory filings. Support the development of regulatory strategies and plans to advance ARIAD products through the regulatory review and approval process globally. Communicate effectively with teams and management. Participates on development teams to represent the functional area. Review and interpret regulatory correspondences and guidances Interact proactively with other ARIAD functions, contract research organizations, and partner companies. With oversight, serves as a liaison with health authorities regulatory agencies pertaining to assigned products/teams. Support the preparation, review, and approval of compliant regulatory documents throughout the product lifecycle. Assist in the review and provide regulatory advice for documents prepared by other departments. Work effectively with regulatory colleagues specializing in CMC and Operations to continuously improve regulatory systems, teamwork, and efficiency. Contribute to improvements in department operating procedures. Remain current with evolving regulatory procedures and practices, and provide guidance to ARIAD project teams. Requirements BS degree, preferably in a scientific discipline, and 3-5 years experience working in pharmaceutical / biotechnology organization with experience in regulatory affairs. Expert project management and interpersonal skills is a requirement, as well as excellent written and verbal communication ability. Familiarity working with electronic document management and submission platforms is desired. Experience in oncology, or post-marketing experience is preferred. Job Location Cambridge, Massachusetts, United States Position Type Full-Time/Regular
Phama Job Categories: 
USA
Regulatory Affairs

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