Program Planning and Regulatory Compliance Manager - Billerica, MA

Organisation Description
EMD Serono, Inc. is a leader in US biotechnology, focusing on reproductive health, metabolic endocrinology, and neurology. More than 500 people work in the world-class facilities in Rockland, MA, and approximately 250 work in the field.
Description

PURPOSE OF THE ROLEDirectly attached to the Site Direction, the principle mission is to manage the regulatory affairs on site. KEY TASKS & RESPONSIBILITIESTo assist the different department managers in the setting-up of action plans and projects.Site focal point for all actions or requests from other entities of the group concerning regulatory affairs.Proposes solutions and cooperates with the different departments in managing regulatory affairs.Write CMC modules for clinical phases concerning activities where the site is directly involved (Drug substance manufacturing, cell bank systems, viral safety of cell culture process...).Prepare answers to regulatory authorities in collaboration with corporate organization. Provide regulatory advice to the site management for compliance of new projects.Bring a technical expertise to the registration files and operation of Regulatory Authorities. Knowledge of the project management and tools are essential.The knowledge of the site and manufacturing processes allow to help in the development of the adequate action plans for support of regulatory filings.To support project teams in order to supply regulatory information in time for filing.Substitutions of the activities of Planning Manager if necessary:Concerning the follow-up for the action plans, the follow-up of the projects and the communication with the services and teams of the group, substitution is ensured by the Site Director.Concerning the management of Regulatory Affairs, substitution is ensured by the Site Director.Planning Manager will have to be able to ensure the substitution of the Site Director with regard to the relationships to the management of the group.Assist Management in the follow-up of the special projects and can represent the site for the follow-up of multisite projects.
EDUCATION/PROFESSIONAL COMPETENCIESThe holder must have the technical skills relating to the establishment of regulatory files as well as a practical knowledge of recombinant protein production methods. LANGUAGESFluent English is required. SKILLS & COMPETENCIESAs well as good experience in project management, it is necessary to have a team spirit, ability to listen, communicate, analyze processes, analyze needs and coordination.