Regeneron Pharmaceuticals

Associate Manager, Regulatory Records Management


PayCompetitive
LocationRemote
Employment typeFull-Time

This job is now closed

  • Job Description

      Req#: R25756

      The Associate Manager, Regulatory Records Management will be responsible for Regulatory Operations strategies and support initiatives related to systems, tools, and processes in Regulatory submissions, publishing, data standards, and user engagement.

      In this role, a typical day might include the following:

      • Assists with identifying future needs for records management within Regulatory Operations and facilitates the process of maturing ideas into initiative proposals.
      • Contributes to the evolution of record management, innovation and process efficiency
      • Assists with evolution of the framework for embedding innovation, process efficiency and record management
      • Assists with activities related to the implementation of new Regulatory Operations’ systems, tools, business improvements, and procedural documents.
      • Supports the adoption of new or updated Health Authority regulations, mentorship, and specifications as it applies to records management.
      • Supports collaborator engagement and communication throughout the life cycle of initiatives to enable informed decision-making and organizational agreement.

      This role might be for you if:

      • Pharmaceutical experience specifically in Regulatory Operations either Regulatory Information Management, Regulatory Submission Project Management, or Regulatory Publishing.
      • Knowledgeable of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, etc).
      • Experience working with information management systems and tools (eg, electronic document management systems, Registration systems, validation tools, eCTD/NeeS viewing, agency gateways/portals, etc).

      To be considered, we are looking for applicants to have 2+ years of experience within Regulatory Operations. We also expect you to be in the office a couple days a week.

      #GDRAJOBS #LI-HYBRID

      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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

      The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

      Salary Range (annually)

      $92,500.00 - $150,900.00
  • About the company

      Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York.

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