OverviewAssociate 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 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 / 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 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 able to manage processes to 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. For other countries\' specific benefits, please speak to your recruiter.
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.
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 is to verify information regarding a candidate prior to the commencement of employment (identity, right to work, educational qualifications, etc.).
Benefits: Work From Home
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