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Regulatory Records Management Specialist

Employer
Regeneron Pharmaceuticals, Inc.
Location
Working from Home
Start date
May 24, 2022

View more

Discipline
Clinical, Clinical Medicine, Regulatory
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including ophthalmology, hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.

The Regulatory Records Management Specialist will drive Regulatory Operations strategic records management activities in support of ongoing or newly identified initiatives. You would own the delivery of a records management roadmap to specifically support initiatives related to systems, tools, and processes in support of Regulatory submissions, publishing, data standards, and user engagement. You would also support Regulatory Operations compliance with changing Regulatory Agency regulations, guidelines, specifications (eg, FDA, EMA, ICH, etc), and internal policies and procedural documents.

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

  • Identifies 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 within Regulatory Operations.
  • Supports evolution of the framework for embedding innovation, process efficiency and record management within Regulatory Operations.
  • Lead records management activities related to the implementation of new Regulatory Operations’ systems, tools, business enhancements, and procedural documents.
  • Supports the adoption of new or updated Health Authority regulations, guidance, and specifications as it applies to records management.
  • Coaches and mentors staff as requested to build expertise of how to effectively drive record management and organizational transformation

This role might be for you if:

You have previous Life Science experience specifically in Regulatory Operations either Regulatory Information Management, Regulatory Submission Project Management, or Regulatory Publishing.

You are Knowledgeable of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, etc).

You have worked with Regulatory information management systems and tools (eg, electronic document management systems, Registration systems, validation tools, eCTD/NeeS viewing, agency gateways/portals, etc).

You have familiarity with Veeva Vault or Lorenz suite preferred.

You have knowledgeable of record management techniques and tools preferred.

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.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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