Senior Manager, Regulatory Intelligence

4 months ago


Dublin, Ireland Regeneron Pharmaceuticals, Inc Full time

This role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization. This position will also serve as a lead Reg Intel contact in support of cross-functional requests and initiatives from the Global Clinical Development organization and various functions within the organization’s GxP framework.

In this role, a typical day might include:

Project Management and leadership in the delivery of regulatory intelligence research services and information

Collaborating on the development and refinement of regulatory intelligence processes and procedures to build efficiencies with more senior leaders

Managing more complex intelligence query requests from internal stakeholders

Serving as the functional lead on cross-functional organizational level projects or initiatives in supporting of GxP compliance or requirements

This role might be for you if can:

Monitor and analyze the external regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders

Monitor and analyze global regulatory intelligence sources for the most current changes and information in the drug development space

Assess regulatory intelligence information for relevance and impact to company’s internal processes, drug development projects and/or regulatory strategies

Identify business critical aspects and communicate effectively to internal stakeholders

Support project teams, functions and departments through the collection and distribution of requested regulatory intelligence information.

Provide regulatory intelligence in support of a range of operational study design and operational planning activities. This includes regular updates on new information that could impact clinical trial execution as well as ad hoc requests to input into feasibility.

To be considered for this opportunity, you must have the following:

Advanced life science degree or related field

Minimum of 7 years experience in the biotech/pharmaceutical industry with a strong focus in Regulatory Intelligence

Good understanding of the drug development and commercialization process, with a focus on clinical development and trial execution

Experienced in understanding and interpreting regulatory guidelines and documents

Ability to research, analyze and extrapolate critical regulatory information, with a focus on clinical requirements and recommendations

Please note, this role requires you to work 3 days onsite weekly out of our New York or New Jersey offices. If you are not local and qualify, we can offer a relocation package

#GDRAJobs #GDPSJobs



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