Regulatory Sciences Project Manager
|Posted on:||Friday, July 13, 2018|
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Summary: Responsible for overseeing technical writing activities which include gathering input and data in order to write internal scientific reports and documents for pharmaceutical regulatory submissions.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Oversees and assigns projects/work load to other technical writer(s).
• Independently prepares or assists with the preparation of a variety of CMC regulatory documents to support all phases of drug development.
• Collaborates with research and development and manufacturing personnel in the preparation and review of regulatory documents; providing feedback on format and content and guidance in general. Keeps management and others informed on progress of documents.
• Interacts with regulatory authorities from US, Canada, and other international health agencies in support of the CMC modules of new drug submissions, biologics license applications, amendments and other regulatory documents.
• Responsible for review and revision of product lifecycle documents including, but not limited to product specifications, validation protocols and reports, and process development reports.
• Maintain database of regulatory commitments to regulatory authorities and communicate within the organization to ensure compliance.
Education and Experience: