Associate Director, Regulatory Intelligence

Regeneron ,
London, Greater London
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Overview

Job Description

This role is responsible for providing decision makers with the knowledge needed to act and make decisions faster. The individual fulfilling this role will interact with staff at various levels to connect their needs with the evolving regulatory climate to enhance the business strategy. This role will also assist in forecasting, developing, and managing resource demand, requirements and capacity planning for the regulatory intelligence function. This position will support activities and requests from all organizations within GxP framework with a primary focus on the European region. Regulatory Intelligence (Reg Intel): * Lead and mange junior regulatory staff in the following areas * Monitor new, revised or emerging regulatory requirements from a global to a local level * Notify teams and decision makers with regulatory information to enable them to refine strategies and better manage potential risks * Write succinct summaries on regulatory requirements and information that clearly communicates relevant implications, expectations and potential impact to business policies, process and strategies * Review, comprehend and track relevant regulatory information as it relates to the business and stakeholder requests * Accurately organize regulatory intelligence information in terms of area and subject * Identify and track key regulatory dates and deadlines for feedback on proposed regulations, rules and guidances * Identify emerging regulatory trends * Support requests from cross functional departments in providing regulatory intelligence * Develop a data gathering and escalation method to capture and communicate regulatory information and trends that impact clinical development * Support strategies and information requests for filings and submissions * May liaise with Legal to ensure consistency in interpretation of regulatory information * May serve as the Reg Intel lead on the organization's cross-functional teams with new intiatives foces on changes to internal processes, policies and standards based on emerging regulatory intelligence information * May develop recommendations to draft rules and guidance documents by Health Authorities with regard to how they should be written or revised in collaboration with internal stakeholder \\ * Resource Planning & People Management * Support Reg Intel's resource planning and forecast needs * Manage forecasts as new projects emerge on an ad hoc basis, as well as quarterly re-forecasting for ongoing projects * Monitor the industry for quality and reliable regulatory intelligence resources * May manage multi regional team - * Ability to review and understand regulatory information * Understanding of compliance issues, regulatory drivers, and terminology * Excellent attention to detail and project management skills * Experience in people management * Highly organized * Ability to work independently but provide value added outcomes * Ability to foster constructive relationships regardless of role or level * Effectively copes with ambiguity and adaptable to changes in directives * High integrity and proactive * A minimum Bachelor's degree is required * A focused degree in science or equivalent is a plus * A minimum of 8+ years of experience in the clinical research industry * Knowledgeable about regulations, regulatory pathways and approaches * Knowledgeable about drug development lifecycle * Experience navigating through information from Heath Authorities such as FDA, EMA, and Health Canada 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. Employment Type: Regular Employee

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