Associate Director – Risk Management
Regeneron
full-time
Posted on:
Location Type: Remote
Location: United Kingdom
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Job Level
About the role
- responsible for assisting in the operations, execution and oversight of global and local drug safety risk management activities as part of Regeneron’s pharmacovigilance (PV) requirements for the worldwide portfolio.
- account for assisting in all elements of planning, overseeing status reporting, managing risks and issues, collaborating with stakeholders, developing risk management tools, and proactively communicating with stakeholders on the delivery of Risk Management in support of the portfolio and RMCoE vendors.
- responsible for providing operations and oversight of the execution and tracking of Global and Local Risk Management Plans that require addition risk minimization measures (aRMMs).
- support the development, execution, and maintenance of Core Implementation Plans (CIPs) and associated materials and the Local Implementation Plans (LIPS) and associated materials.
- responsible for creating and obtaining internal approval of Global and Local aRMMs materials, and Local Implementations Plans (LIPS).
- provide and/or follow-up on aRMMs and LIP tracking and key performance metrics for RMCoE.
- follow Risk Management planning and processes to ensure compliance with global regulations as well as Regeneron Standard Operating Procedures (SOPS) and Work Instructions (WI).
- ensure risk management activities allow for effective preparation for inspections/audits.
- ensure communication of Risk Management activities and deliverables are clearly and accurately communicated between GPS/Regulatory/Qualified Person for PV Office (QPPVO/LCPPV)/External vendors and cross functional partners.
- ensure the risk assessment processes are continuously improved to reflect best practices, regulatory trends, and guidelines working across with GPS, and Regeneron stakeholders.
- support and/or participate in Regulatory Agency approvals and/or interactions including audits/inspections, PSUR,PBRERS.
Requirements
- Preferred advanced life sciences degree: MPH, PharmD is an advantage.
- 5+ years' experience in EU risk management operations, experience in the pharmaceutical industry required.
- 5+ years of leading a matrix role that encompasses working across all areas of an organization and managing cross-functional teams.
- Preferred minimum of 3 years of international pharmaceutical activities
- Strong leadership and communication capabilities and presence, influencing skills, interpersonal, verbal, and written communication skills organizational and workload planning skills along with the ability to manage multiple different projects simultaneously.
- Preferred experience managing initiatives related to drug development, risk management/ PV operations and global regulatory requirements.
- Demonstrated strength in analytical skills and attention to detail.
- Demonstrated strength in oral/written communication, negotiation, and interpersonal skills.
- High level analytical skills - Detail oriented, independent, and manage processes to both establish timelines and ensure timelines are met.
- Excellent organizational skills.
- Strategic Thinking – Demonstrated ability to analyze, frame, and communicate complex issues, including writing and presentation proficiency.
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
risk managementpharmacovigilancerisk assessmentdata analysisproject managementregulatory complianceaudit preparationperformance metricsdrug developmentglobal regulatory requirements
Soft Skills
leadershipcommunicationinterpersonal skillsorganizational skillsworkload planningstrategic thinkingnegotiationattention to detailinfluencing skillsanalytical skills
Certifications
MPHPharmD