argenx · 1 day ago

Regulatory Intelligence Mgr, Global RA

Boston, MA

Full-time

Remote

Mid, Senior Level

5+ years exp

Maximize your interview chances

BiotechnologyClinical Trials

Insider Connection @argenx

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

Identify and permanently monitor the information needs of the internal stakeholders.

Participate in the external environment parsing, extracting relevant information.

Analyze and interpret changes to the regulatory landscape.

Keep up to date with latest guidelines from Health Authorities e.g.: EMA, MHRA, FDA, PMDA and other Regulatory bodies e.g.: EU Commission, ICH, ISO, etc...

Prepare the concise and comprehensive reports/summaries/presentations/newsletters on regulatory updates for communication with internal stakeholders.

Liaise with all functional areas of the organization and if applicable argenx vendors on RI matters.

Identify and maintain an internal network of SMEs across Functional Areas and Geographies as needed to support RI activities.

Work in collaboration with the RI related SME(s) and quality group to support gap analysis, risk assessment and strategize proposals for implementation of regulatory changes. Identify and classify potential risks and opportunities arising from regulatory landscape changes.

Develop a full set of standardized tools, templates and methods to support the RI activities as well as their inter-correlation with the internally gathered regulatory intelligence.

Participate in the selection, testing and implementation of RI specific tools as they are brought in.

Depending on areas of expertise, participate in external regulatory intelligence networks, forums and conferences to voice argenx positions if relevant, bring back relevant information for internal dissemination and proactively keeping abreast with Industry’s best practices.

If applicable, coordinate argenx feedback on health authorities consultations or other regulatory landscape changes.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory IntelligenceLife SciencesPharmacyRegulatory AffairsGenAI technologyProject ManagementNetworking SkillsEnglish Language

Required

Advanced degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field with strong understanding of the global health authority regulations framework.

5-10 years of experience in biopharmaceutical industry with at least 5 years of experience in a regulatory intelligence function.

US region RI experience being a must.

Proven track record of monitoring and interpreting regulatory changes and their impact on the organization.

Hands-on knowledge of Regulatory Intelligence methods, typical databases and tools.

Ability to monitor trends, detect shifts in requirements and align internal organization priorities and actions accordingly.

Strong project management and prioritization skills, proven ability to effectively manage multiple tasks and priorities in a fast paced environment.

Strong communication and networking skills to identify and maintain an internal network of subject matter experts (SMEs).

Collaborative mindset to work effectively with SMEs and Quality groups.

Analytical mindset, attention to details.

Perfect command of English.