Manager, CMC Regulatory Affairs

Location
Rensselaer, NY, United States
Posted
Oct 26, 2020
Ref
20828BR
Required Education
Bachelors Degree
Position Type
Full time
This position involves utilizing a proven understanding of CMC elements and regulatory requirements to support, and provide guidance to, the Industrial Operations and Product Supply (IOPS) team in regulatory strategy implementation. This position also supports all CMC regulatory filing activities for pre-INDs, INDs, IMPDs, CTAs and BLAs/MAAs and the tracking of regulatory commitments.
In this role, a typical day might include the following:
  • Develops and maintains a solid understanding of regulatory requirements and the available regulatory guidance documents and resources.
  • Assists with the planning, scientific writing and critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, amendments, and supplements (eCTD) to ensure conformance with regulatory requirements and to provide a high-quality regulatory submission.
  • Must have excellent communication skills, both written and oral.
  • Must be able to manage through ambiguity and make decisions based on regulatory requirements while working independently and with various cross-functional teams.
  • Acts as product liaison and corresponds with FDA for CMC related submissions and information requests.
  • Assesses CMC changes against regulatory filings to ensure compliance.
  • Assesses manufacturing processes/specifications against regulatory filings for clinical product release requests.
  • Maintains awareness of project timelines in order to ensure on-time submissions.
  • Participates as needed in agency meetings to effectively communicate Regeneron positions and understand agency feedback to support submissions.
This role might be for you if:
  • Posses a Strong biopharmaceutical or regulatory background.
  • Attention to detail.
  • Ability to interpret, communicate, strategize.
  • A strong work ethic is a must.
  • Ability to collaborate with different teams and to apply experience and "lessons learned" is essential.

We seek 5 years experience in the pharmaceutical industry (BS/BA) or two years in industry with advanced degree.

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.