Manager, Global Regulatory Affairs
About the Company
EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.
Description
• Support the preparation of regulatory documentation for submission to regulatory agencies
• Regulatory Agency liaison for CTAs/INDs and maintenance activities.
Functional Tasks
• Regulatory Project Team Member for smaller project, e.g. Life cycle management project
• Regulatory Affairs sub-team member.
• Trial Team member
• Prepare regulatory documents
• Review of protocols and some regulatory documentation
Managerial Tasks
• Constitute and manage Regulatory Subteam if Regulatory Project Team Member
• Manage and prepare CTAs WW until approval of particular studies
• Act as agency liaison for CTAs/INDs and maintenance activities
Qualifications
EDUCATION/LANGUAGES
• Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
• Excellent spoken and written English
PROFESSIONAL & TECHNICAL SKILLS
• Minimum of 5 years' industry experience of which at least 3 years' regulatory experience
• Experience in preparation and submission of parts of a submission in at least one ICH region and clinical trial applications (WW)
• Experience in project team membership
• Experience with regulatory agency interactions and preparation of documents for regulatory agency interactions
• Experience with regulatory maintenance activities for authorizations in a local affiliate or head office
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Awards & Recognition
June 2009, The Boston Business Journal recognizes EMD Serono as one of the Best Places to Work! May 2009, The Scientist magazine names EMD Serono one of the best place to work in the life sciences industries! October 2008, EMD Serono Named as a Top Employer by Science Magazine!more
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About MassBio
MassBio is a not-for-profit organization committed to advancing the development of critical new science, technology and medicines that benefit people worldwide.
Founded in 1985, MassBio represents over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, and works to advance policy and promote education, while providing member programs and events, industry information, and services.
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