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- Tasks: Assist in global drug safety risk management and collaborate with stakeholders.
- Company: Join Regeneron, a leader in innovative biopharmaceuticals.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real impact in drug safety and risk management.
- Qualifications: 5+ years in EU risk management and strong leadership skills required.
- Other info: Dynamic role with opportunities for international collaboration and career advancement.
The predicted salary is between 43200 - 72000 £ per year.
The Associate Director, Risk Management Associate (RMA) will be a member of Regeneron’s Risk Management Center of Excellence (RMCoE) and will report directly to the Director, Risk Management Lead (RML). This position is 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.
The role will be accountable 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.
You will be responsible for providing operations and oversight of the execution and tracking of Global and Local Risk Management Plans that require additional risk minimization measures (aRMMs). Key responsibilities include supporting 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).
- Responsible to 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.
- Maintain expertise in the regulatory environment, regulations, and requirements for Global Risk Management.
Other duties as assigned.
Qualifications
- 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.
Associate Director, Risk Management employer: Regeneron Pharmaceuticals
Contact Detail:
Regeneron Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Risk Management
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those at Regeneron. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by diving deep into Regeneron's values and recent projects. Show us you’re not just another candidate but someone who truly gets what we do.
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. We love hearing about your past experiences and how they relate to risk management!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining us.
We think you need these skills to ace Associate Director, Risk Management
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Associate Director, Risk Management role. Highlight your relevant experience in risk management and pharmacovigilance, and show us how you can contribute to our team at Regeneron.
Showcase Your Skills: We want to see your leadership and communication skills shine through in your application. Use specific examples from your past experiences that demonstrate your ability to manage cross-functional teams and handle complex projects.
Be Clear and Concise: When writing your application, keep it clear and to the point. Avoid jargon and make sure your key achievements stand out. We appreciate straightforward communication, especially in a role that involves risk management.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. We can’t wait to see what you bring to the table!
How to prepare for a job interview at Regeneron Pharmaceuticals
✨Know Your Risk Management Stuff
Make sure you brush up on your knowledge of risk management principles, especially in the pharmaceutical industry. Familiarise yourself with Regeneron's specific processes and any recent developments in pharmacovigilance to show that you're not just a candidate, but a well-informed one.
✨Showcase Your Leadership Skills
Since this role involves leading cross-functional teams, be ready to share examples of how you've successfully managed projects and influenced stakeholders in the past. Use the STAR method (Situation, Task, Action, Result) to structure your responses and highlight your leadership capabilities.
✨Prepare for Regulatory Questions
Expect questions about global regulations and compliance in risk management. Brush up on the latest guidelines and be prepared to discuss how you've navigated regulatory challenges in previous roles. This will demonstrate your expertise and readiness for the responsibilities of the position.
✨Communicate Clearly and Confidently
Strong communication skills are key for this role. Practice articulating your thoughts clearly and confidently, both verbally and in writing. Consider doing mock interviews with a friend or using video tools to refine your delivery and ensure you come across as professional and engaging.
