Senior Specialist CMC Regulatory Affairs

Location
Rensselaer, NY, United States
Posted
Mar 21, 2019
Ref
16069BR
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
Act as the CMC Regulatory Affairs representative for a subset of programs at the IOPS facility. Evaluate proposed changes to IOPS documents and procedures to determine regulatory impact.

Responsibilities

• Plans and conducts critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, and supplements to ensure a high quality regulatory submission and approval

• Reviews Change Controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and ensures that CMC related changes are reported to competent authorities in accordance with regulatory requirements, as necessary

• Reviews all deviations and provides regulatory assessments to support IOPS

• Provides assistance to CMC Regulatory Affairs management in preparing meeting requests, briefing books, and responses to information requests received from various Health agencies.

• Tracks and/or completes CMC regulatory commitments for INDs/IMPDs, CTAs, and BLAs/MAAs

• Provides CMC-related guidance to IOPS so that their short-term and long-term goals are achieved on time and with highest quality

• Participates in CMC project team meetings and provides current regulatory requirements that pertain to stability studies and analytical characterization tests
Requirements
Education and Experience:
Requires BA/BS degree in a scientific discipline or related field and 2 to 4 years of relevant experience in biotech/pharmaceutical industry. Education and/or prior experience in Regulatory Affairs preferred.

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.