Manager, Regulatory Publishing

Location
Tarrytown, NY, United States
Posted
Oct 17, 2020
Ref
21760BR
Required Education
Bachelors Degree
Position Type
Full time
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.