CMC Regulatory Sciences Specialist

Rensselaer, NY
Aug 05, 2019
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 providing Chemistry, Manufacturing, and Controls (CMC) support across Regeneron's sites. Routine activities include dossier development for clinical trial applications, marketing applications, amendments, post approval variations, and other regulatory submissions.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Prepares global CMC documents and sections for a variety of clinical and commercial biopharmaceutical regulatory submissions, ensuring that all submissions are complete, accurate, and meet relevant requirements.

• Manages and coordinates the authoring, review, and finalization of CMC documents, and responses to CMC-related inquiries from Regulatory agencies, in accordance with submission timelines, keeping all stakeholders, including external partners, informed of progress.

• Collaborates and develops excellent relationships with functional area and cross functional teams, contract manufacturing organizations, and global Regulatory partners.

• Applies in-depth understanding of regulatory guidance and regulations, as well as industry and government agency best practices and trends.

• May review relevant CMC documents and reports for completeness, accuracy and compliance with regulations and regulatory guidance.

• May proactively identify issues and contributes to the development of appropriate strategies to mitigate risk.

• May assist in preparation for meetings with global regulatory authorities.

• May contribute to developing CMC regulatory strategy.

• May review regulatory submission documents to ensure that all submissions are complete, accurate and meet relevant requirements.

Knowledge and Skills:

• Excellent written and verbal communication skills.

• 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 relevant drug development regulations and guidelines (i.e. FDA regulations and ICH guidelines) as well as an understanding of CGMPs (Current Good Manufacturing Practices).

• Strong skills in planning, critical thinking, and problem-solving.

Education and Experience:

• Requires BS/BA, preferably in a scientific related field. May substitute relevant experience in lieu of educational requirement.

• Relevant experience in the biopharmaceutical industry highly desirable

*Title level (Associate Specialist or Specialist) will be determined based on qualifications 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.