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Director Regulatory Intelligence

Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: May 14, 2022

Job Description:

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 Director of Regulatory Intelligence will lead intelligence staff across the regions in their analysis of policies and information across the drug development landscape while driving the departments vision and goals. Lastly, they will be important in finding opportunities for standardizing and implementing intelligence systems, processes and methodologies with potential impact on REGN's products, processes, strategy and goals.In this role, a typical day might include the following:

  • Lead requests for global country-level regulatory information from various GxP partners
  • Handle the development of custom reports to support regulatory compliance and advise strategy
  • Collaborate with partners to support any compliance and process initiatives
  • Own the review and refinement of regulatory policy positions and recommendations by developing written comments reflecting REGN's priorities for submission to Regulatory Authorities
  • Supervise the evaluation of new regulatory intelligence data sources and service providers
  • Serve as Reg intel lead on highly sophisticated organization process or policy initiatives, or implementation taskforce(s) not led by Reg Intel
  • Provide managerial oversight of Reg Intel managers leading moderate to high complexity cross-functional interpersonal initiatives
  • Direct the execution of daily activities and responsibilities junior staffThis role might be for you if:You have a comprehensive understanding of regulations and guidance governing drug development across a product lifecycle.You are experienced in sourcing and assessing relevant country level regulatory policy and intelligence informationYou are able to work collaboratively across all organizations in using internal SMEs to influence Agency guidance and regulationsYou have solid understanding of intelligence tools and methodsYou have In-depth knowledge of EU CTR requirements is a plusYou have led direct reportsTo be considered, you'll need at least 10 years of experience within the life science industryDoes 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.

Keywords: Regeneron Pharmaceuticals, Inc., Newark , Director Regulatory Intelligence, Executive , Basking Ridge, New Jersey

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