CMC Regulatory Sciences Specialist
|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 researching all CMC aspects of clinical and/or commercial manufacturing and for summarizing the information and data as outlined in regulations and guidance (e.g., ICH guidelines) for CMC documents such as global submissions to regulatory agencies, product quality reviews or other documents, as required.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Applies in-depth understanding of regulatory guidance and regulations, as well as industry and government agency best practices and trends, to prepare CMC documents and sections for a variety of biopharmaceutical regulatory submissions, product quality reviews or other documents, as required.
• Researches and utilizes information from existing documents and sources including records, reports, protocols, and project team communications to author submission documents in a uniform style and language for regulatory compliance.
• Collaborates with project teams to manage and coordinate the authoring, review, and finalization of CMC documents in accordance with submission timelines, keeping all stakeholders, including external partners, informed of progress.
• Coordinates the timely and accurate assembly of responses to inquiries from Regulatory agencies on CMC content of regulatory submissions.
• Reviews ancillary CMC documents and reports for completeness and accuracy and for compliance with regulations.
• Identifies project issues and contributes to development of alternate strategies – may contribute to developing CMC regulatory strategy.
Knowledge and Skills:
Education and Experience: