Manager, Regulatory Intelligence
4 months ago
Regeneron is seeking a Manager to join the Regulatory Intelligence Group
In this role, a typical day might include:
The Regulatory Intelligence Manager performs proactive global monitoring and surveillance of changes in the regulatory landscape focused on the drug development lifecycle, i.e., preclinical through commercialization, as well as disseminate relevant regulatory intelligence information to Regeneron stakeholders. This role will also prepare responses to cross-functional requests and initiatives from assigned departments or functions within the organization’s GxP framework. The Regulatory Intelligence Manager will also facilitate processes to hold cross-functional discussions and coordinate commenting on industry draft policy documents open for public consultation. The above activities should be executed independently and, in some cases, with guidance/support from Sr. Team members as applicable.
Regulatory intelligence information monitored covers a global scope. The Regulatory Intelligence Manager will support intelligence deliverables across all GxP functions, but will likely focus on one to a few functional areas. This role may specifically focus on supporting the following topic areas: Pharmacovigilance, Pharmacoepidemiology, Cell and Gene Therapy.
This role might be for you if can:
Monitoring, Surveillance and Provision of Intelligence Information
Perform the following duties independently:
Proactively monitor the external regulatory environment and intelligence sources as it relates to drug and device development, including regulations, guidance, and other information, from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders.
Assess regulatory intelligence information for relevance and impact to company’s internal processes, drug development projects and/or regulatory strategies.
Identify business critical aspects of such information and communicate effectively to internal/external stakeholders as applicable.
Regularly review and assess incoming regulatory information in global regulatory intelligence database, and distribute relevant updates to reviewers from appropriate functions within the company.
Identify relevant regulatory guidance documents open to potential comments from industry.
Facilitate regulatory intelligence review meetings and/or learning series sessions.
Assist in the collection and maintenance of regulatory intelligence newsletter content and distribution to the organization.
Manage intelligence query requests from internal stakeholders, prepare and deliver responses. Such deliverables may vary in scope and complexity based on business need, ranging from short responses to larger reports, trackers, presentations, etc.
Supporting Commenting Efforts for New /Revised Regulatory Policy Documents
May assist with cross functional impact assessment discussions and/or drafting of comments for submission to industry organizations, Health Authorities and other stakeholders.
Perform project management and/or related administrative tasks, such as managing and tracking timelines, taking meeting minutes, etc.
Regulatory Intelligence Systems, Processes, and Procedures
Share/Input data into systems or tools to enable effective information management of country level operational intelligence data.
Collaborate on the development and refinement of internal regulatory intelligence processes and procedures to build efficiencies with more senior leaders and cross functional areas.
Manage content of, and updates to, the Regulatory Intelligence SharePoint and intranet sites
Support cross-functional projects and continuous improvement-related activities, as necessary.
To be considered for this opportunity, you must have the following:
Minimum Bachelor's Degree. Advanced life science degree or certification in Regulatory Affairs Sciences preferred.
Minimum of 5 years’ experience in the biotech/pharmaceutical industry or health authority
Solid understanding of the drug development and commercialization process, globally (US, JP and EU at a minimum).
Experience and solid knowledge of Pharmacovigilance specifically
Proficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDx
Experienced in understanding and interpreting regulatory guidelines and documents.
Proficient in the navigation of regulatory intelligence database(s).
Experienced in the monitoring and sourcing of regulatory requirements information in pharmaceutical industry.
Ability to research, analyze and extrapolate critical regulatory information. Can assess potential impacted functional areas from an executive summary of regulation or guidance.
Highly organized and able to work independently to meet deliverable on time and on target. “Self-starter”
Team-oriented and strong relationship builder, ability to effectively collaborate with a range of individuals across the organization at all levels.
Attentive to details and focused on quality output.
Effective communicator - both written and oral - in a multi-disciplinary team environment; experience communicating with senior management.
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