CMC Regulatory Sciences Specialist

Rensselaer, New York, US
Sep 27, 2018
Required Education
Bachelors Degree
Position Type
Full time
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:

• 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.

• Knowledge of biopharmaceutical development, testing or manufacturing preferred.

• Strong skills in planning, critical thinking, and problem-solving preferred.
Education and Experience:

• Requires BS/BA in a scientific discipline

• Experience in the biopharmaceutical industry highly desirable

• Experience in Microsoft® programs (Word, Excel, PowerPoint), Adobe Acrobat, templates and controlled EDMS systems is preferred

• Experience with statistical analysis a plus

*Title level (Associate Specialist, Specialist, or Senior Specialist) will be determined based on skills and experience relevant to the role.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.