Manager, Regulatory Affairs

Location
Tarrytown, NY, United States
Posted
Feb 12, 2021
Ref
23666BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
This position reports to the Global Regulatory Liaison (GRL), Associate Director or above, and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations, asthma, pain, cancer and infectious diseases.
In this role, a typical day might include the following:
  • Assist in the preparation, compilation, and organization of regulatory submissions (e.g. INDs, BLAs, MAAs, annual reports, IND amendments, BLA supplements, etc.)
  • Ensure timely submission of above in accordance with title 21 CFR and FDA, EU and ICH guidelines.
  • Critically review regulatory documents in addition to performing quality control review for accuracy, completeness, and conformance to appropriate regulations, guidelines, and SOPs
  • Manage regulatory communications, including drafting of letters based on templates
  • Participate in cross-functional team meetings, as required, in collaboration with, and to assist, the GRL
  • Conduct research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy
This role might be for you if:
  • We seek a Ph.D. or PharmD
  • M.S. may be considered on a case-by-case basis
  • 2 years of pharmaceutical industry experience
  • Strong oral and written communication skills
  • Ability to plan and organize effectively
  • Attention to detail and follow through

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.