Associate Director, Risk Management Associate (RMA)

 

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.

 

In this role, a typical day might include:

You will be 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)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 [RS1] [SM2] 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.

 

This role might be for you if:

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 activitiesStrong 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.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.