Sr CMC Regulatory Affairs Specialist
Company: Regeneron Pharmaceuticals
Location: Troy
Posted on: May 4, 2022
|
|
Job Description:
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.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 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 testsThis role might be for you if:Two to five
years of relevant 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.
Keywords: Regeneron Pharmaceuticals, Troy , Sr CMC Regulatory Affairs Specialist, Other , Troy, New York
Click
here to apply!
|