Director, Regulatory Intelligence

Location
Tarrytown, NY, United States
Posted
Apr 26, 2021
Ref
24169BR
Required Education
Bachelors Degree
Position Type
Full time
The Director of Regulatory Intelligence oversees team of intelligence staff across regions in their analysis of global regulatory policy and new information across the drug development landscape. He/She will also seek opportunities for standardizing and implementing intelligence systems, processes, and best practices with impact on REGN's products, processes, strategy and goals.
In this role, a typical day might include the following:
Strategy: The Director leads a Reg Intel team to support intelligence queries and communication of important developments from leading Regulatory and Health Authorities. This includes managing requests for global country-level regulatory information from various GxP stakeholders. This position also manages the development of custom reports and provides strategy for regulatory compliance. He/She serves as regulatory intelligence lead or SME on internal cross-functional committees addressing company-level initiatives to align with requirements mandated by global Health Authorities. We also need the Director to be acting as REGN's lead regulatory contact to external stakeholders regarding regulatory policy (e.g., BIO, TransCelerate, etc).
Regulatory Policy Surveillance & Assessment: The Director leads the sourcing, and QC of new and revised global regulatory information for an impact assessment of relevance and significance to REGN's position. Activities include developing written comments reflecting REGN's priorities for submission to Regulatory Authorities, leading all aspects of team results regarding regulatory intelligence updates, alerts for general awareness and/or proactive planning.
Internal Compliance Advocate: The Director identifies emerging regulatory trends that may necessitate internal changes. He/She will also contribute to the adoption of best practices or development of new (or revisions to) SOPs based on policy impact assessment.
Regulatory Intelligence Continual Improvements: The Director develops and ensures the reporting of key metrics to Executive management, builds standard methodologies for producing operational excellence. The goal is to elevate company-level awareness of Regulatory Intelligence function and services.
Personnel Management: The Director will manage the execution of daily activities and responsibilities of junior staff. He/She will mentor, train, and develop Reg Intel staff in understanding regulatory policy concepts, (strategic) impact and implications across the organization and globally.
This role may be for you if you have:
  • Bachelors Degree required.
  • Minimum 10 years of drug development experience with growing roles and responsibilities. Experienced managing direct reports.
  • Possess comprehensive understanding of regulations governing drug development across a product lifecycle. In-depth knowledge of EU CTR requirements is a plus.
  • Possess solid understanding of intelligence tools and methods.
  • Able to work collaboratively across all organizations in using internal SMEs to influence Agency guidance and regulations.
  • Excellent written and verbal communication, timeline management and leadership skills.

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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.