Senior Manager Regulatory Affairs in Hillingdon - Regeneron Pharmaceuticals

Job Overview

Location
Hillingdon, England
Job Type
Full Time
Salary
TBC
Date Posted
1 day ago

Additional Details

Job ID
43001893
Job Views
1

Job Description

The growing need for EU-specific expertise on our development programs as well as to keep the company compliant on emerging EU legislation and processes has led to the need to create a new position based in one of our offices in Europe, including Dublin (Ireland) and Uxbridge (UK) office. The role is positioned at the Senior Manager level to enable independent working and advanced regulatory input to interactions with EU Regulatory agencies. This role will focus on supporting development activities for oncology programs with ongoing activities in phase 1 through phase 3 and the post-marketing setting. JOB DUTIES: Assist Development teams and Regulatory management in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes.Provide leadership on both late and early-stage clinical development related process and strategy to ensure timely study conduct end to end.Assist clinical teams in study start up and maintenance activities by leading all associated regulatory activities, including but not limited to submissions, addressing agency queries, managing compliance issues.Represent Regeneron in interactions with CROs for a broad range of complex early and late stage clinical studies.As needed, provide leadership for regulatory submission such as scientific advice, paediatric investigational plans, etc…Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).Build the representation of Regeneron's EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required.Further build Regeneron’s regulatory profile in the EU, and serve as a resource for EU knowledge for the global regulatory and development teams.Conduct those activities as deemed necessary under the leadership of the Senior Director of Regulatory Affairs to support program progression.JOB REQUIREMENTS:Advanced degree in a scientific discipline.5+ years regulatory experience with a focus on supporting products through clinical development.Experience providing strategic regulatory input for the development of oncology drugs, ideally those that are biologics (e.g immune-oncology, bispecifics, CARTs)Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) an advantage.Proven track record of supporting EU Clinical Trial Applications through approval and study start up.Ability to negotiate and concisely express clear positions to stakeholders at all levels.Experience of directly working with national regulatory agencies and leading agency meetings face to face, an advantage.Excellent written and verbal communication skills.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.#GDRAJobsJob SummaryJob number: R13790Date posted : 2022-08-04Profession: Global DevelopmentEmployment type: Full time

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