Regulatory Compliance Specialist/Technical Writer

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 ROLECoordinate, write and support Regulatory CMC filings related to the early stage products developed on the Billerica Site. Lead the development of CMC related Regulatory Filings supporting IND's, IMPD's and associated comparability protocols. Coordinate writing and collation of CMC related Regulatiory filings associated with and according to the projects developed at the Billerica Site Stay current with changes within the Regulatory Discipline Regulatory associated research to support current manufacturing approaches Provide technical writing expertise to the Billerica Site Perfroming Regulatory review of all process changes (TrackWise) KEY TASKS & RESPONSIBILITIESTo coordinate with department managers in the setting-up of action plans associated with Regulatory/CMC goals. Site focal point for all actions or requests from internal and other entities of the group concerning regulatory affairs. Insure all Regulatory writing is of high quality and representative of processes. 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 issues related to current and new projects.Bring a technical expertise to the registration files and operation of Regulatory Authorities. Knowledge of the project management and tools are essential. Is recognized by the Regulatory Services of the other Sites of the Group for skills and knowledge. 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. Ability to listen, analyze, drive, motivate, plan and coordinate a team. Good relational ability to interact in a constructive way with all stakeholders. Assist Management in the follow-up of the special projects and can represent the site for the follow-up of multisite projects.
EDUCATION/LANGUAGESBachelor's Degree in Chemistry or Biology or Pharmacy or equivalent Fluent in English PROFESSIONAL SKILLS & EXPERIENCEExpertise in the Pharmaceutical/Biotechnology Regulatory related issues. 5+ years of experience in the Pharmaceutical/Biotechnology Regulatory field Sound awareness of cGMP related issues and health authorities requirements Demonstrated success records in position which influences and interacts with other departments PERSONAL SKILLS & COMPETENCIESStrong results orientation. Strong interpersonal skills and ability to interact constructively with all functions in a matrix based organization. Ability to represent the Company internally and externally. Good verbal and written communication skills. Mature leadership and influencing skills Managerial skills Strong committed team member Strong active listening skills and ability to articulate and formulate in a simple business language Excellent team leader as well as committed team member