Senior CMC Regulatory Sciences Specialist

Location
Rensselaer, New York, US
Posted
Aug 08, 2018
Ref
13933BR
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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 gathering, compiling, and interpreting data associated with the preparation of product quality reviews (PQR). These activities include gathering data and summarizing the information as outlined in procedures, regulations and guidance documents (e.g., ICH guidelines) for the preparation of product quality reviews or other documents, as required.

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

• Compiles and reviews manufacturing data to conduct timely Product Quality Reviews in compliance with regulations and industry guidance. Assesses quality-related information to detect trends and works with Subject Matter Experts to determine the need for actions required in response to those trends.

• Collaborates with manufacturing and quality personnel in monitoring the manufacturing process, as well as preparing and reviewing documents.

• Reviews PQR documents and reports to ensure their completeness, accuracy, consistency and compliance with regulations.

• Rewrites various sources of information into a uniform style and language for regulatory compliance, and assists in developing documentation for instructional, descriptive, reference, and/or informational purposes.

• May present Product Quality Review data to senior management, regulatory agencies, and business partners as needed. May correspond with global business partners and contract manufacturing organizations as needed.

• Supports other teams in the CMC Regulatory Sciences department with the preparation of regulatory documents to support all phases of clinical drug development, as needed.

• Keeps management and other stakeholders such as external partners informed on the progress of projects and documents.

• Identifies project or resource constraints and contributes to the development of alternate strategies.

• Supervisory tasks related to direct reports (e.g, performance management, work distribution and oversight).

Knowledge and Skills:

• Expertise in Microsoft suite (Excel, Word, PowerPoint).

• Strong written and verbal communication skills.

• Strong problem-solving and analytical skills.

• Familiarity with pharmaceutical Good Manufacturing Practices and working in GMP environments preferred.

• Knowledge of FDA and international agency regulations helpful.
Education and Experience:

• BS/BA required, preferably in a scientific discipline.

• 5+ years of relevant experience required.

• Quality Assurance, Regulatory, or biopharmaceutical manufacturing experience highly desirable.

• Prior experience with leading/managing people strongly preferred.

• Proficiency in creating databases and organizing and/or visualizing data.

• Experience with pharmaceutical quality systems highly desirable.

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.

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