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: This individual will provide expertise in translating scientific documents into well thought out, clearly written regulatory submissions.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Provides direction, regulatory, and technical writing expertise on the coordination, preparation and timely submissions of CMC content of global regulatory documents including BLA/MAA, IND/IMPD, responses to information requests and related documents.
- Coordinates with Quality, Manufacturing and Supply organizations on the planning and submission of CMC regulatory documents to support product life cycle management.
- Reviews and edits CMC documents as needed.
- Ensures the accuracy, interpretation, and clarity of written technical information/communications and ensures all documents will meet regulatory requirements.
- Maintains up-to-date knowledge of current and emerging regulations, guidance documents and corporate/industry standards.
- Ensures the timely review and approval of submission components with the designated review teams.
- Directs team of Technical Writers.
Knowledge and Skills:
- Excellent written and verbal communication skills a must.
- Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a high level of attention to detail is a must.
- Strong skills in planning, critical thinking, and problem-solving.
- Continuously drive to improve processes for improved performance.
- Education and Experience
- Requires BS/BA in Chemistry, Biology or related field (advanced degree preferred) with at least 6+ years of relevant experience, including 3+ years of experience working in the biopharmaceutical manufacturing industry writing CMC regulatory documents.
- Leadership and/or managerial experience required.