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Associate Manager, Regulatory Publishing

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, NY, United States
Start date
May 29, 2021

View more

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

Job Details

Summary: Responsible for leading Regulatory Publishing staff who format and publish electronic documents, build Regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs, including their amendments and supplements, in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). Responsibilities:
  • Lead staff who electronically format, publish electronic documents and builds Regulatory submission deliverables.
  • Ensure quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
  • Provide guidance to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
  • Provide guidance on good documentation and submission practices
  • Assist with developing and maintaining Regulatory document processing and Regulatory submission publishing standards and procedures in accordance with all applicable Regulatory regulations, mentorship, and specifications.
  • Identify regulatory system improvement needs or technical issues and works closely with systems and technical support staff to identify, develop, and implement solutions
  • Assist with regulatory inspection activities
  • Provide document authoring template training.
  • Maintain Authoring Template Library and work with cross-functional teams to develop and maintain templates
  • Collaborate with vendors who support Regulatory operations related tasks.
  • Communicate the need for additional resources to management as needed.
  • Function as a contributor, as needed.
  • Provide support and backup to management as needed. Requirements:
  • Bachelor's degree in related field.
  • Strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
  • Working knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required.
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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