Senior Specialist, Regulatory Affairs CMC

Location
Rensselaer, NY, United States
Posted
Oct 29, 2020
Ref
21667BR
Required Education
Bachelors Degree
Position Type
Full time
Act as the CMC Regulatory representative for a subset of programs at the IOPS facility. Evaluate proposed changes to IOPS documents and procedures to determine regulatory impact.
In this role, a typical day might include the following:
  • 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 proficient authorities in accordance with regulatory requirements, as vital
  • We will review and assess all deviations and provides regulatory assessments to support IOPS
  • Provides assistance to 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 mentorship to IOPS so that their short-term and long-term goals are achieved on time and with the highest quality
  • Participates in CMC project team meetings and provides current regulatory requirements that pertain to stability studies and analytical characterization tests

Wee seek Two to five years of proven experience in biotech/pharmaceutical industry. Advanced degree in lieu of experience will also be considered.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.