Functieomschrijving
Regeneron is seeking a Director, PV Hub to join our Patient Safety organization!
In this role, a typical day might include:
The Director, PV Hub oversees country and/or regional level PV execution within their assigned region and ensures that local safety activities are performed in accordance with global standards, local regulatory requirements are met, and all country-generated safety data are accurately and timely integrated into the global PV system. This role serves as the escalation point for local execution issues and as the conduit between local operations and global oversight functions.
This role might be for you if can:
Maintain a comprehensive understanding of local legislation and Health Authority requirements and keep Worldwide Operations Office (WWOO) leadership informed of updates or changes to local requirements or processes (e.g., SOP addenda, safety communications, labeling updates, and local submission requirements) in alignment with country-specific regulatory requirements
Track local process status, changes, and risks to drive consistency and continuous improvement for hub’s geographic markets, including maintaining and monitoring via common tool (e.g., tracker, dashboard)
Develop innovative approaches to delivering on core activities that integrate in new technologies, including AI
Ensure country compliance with the global PV quality system, supporting inspections, audits, CAPAs, and timely resolution of deviations or non-compliance
Serve as local safety PoC to coordinate with global GPS (e.g., PV Enablement, CER, SS) and non-GPS (e.g., Med Affairs, Regulatory) teams to:
Guide and inform global teams on local requirements and ensure compliance with local legislations
Coordinate with other PV hub(s) as needed for contributions to activities and/or local documentation
Shape compliant programs that provide high quality adverse event reports
Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines
To be considered for this opportunity, you must have the following:
Minimum Bachelor’s Degree (Advanced Degree preferred) with 12+ years of PV experience and demonstrated achievements in patient safety
Experience supporting regulatory inspections, audits, and quality issue management at the country or regional level
Preferred experience with AI technologies
Ability to coordinate across functions and cultures, operating effectively as an execution and escalation lead rather than a policy owner
Strong organizational and communication skills, with the ability to surface local risks early and drive resolution through global governance channels
#GDPSJobs
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.
Salary Range (annually)