Senior Specialist, Regulatory Operations

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.Bristol Myers Squibb IrelandBristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units.Ireland is home to External manufacturing’s global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO’s) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network.This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites. In Ireland, External Manufacturing has two sites; Global Headquarters based in Dublin 15 and a distribution centre in Shannon, Co Clare.For more information about Bristol Myers Squibb, visit us at BMS.com/ieThe RoleBMS External Manufacturing is looking to recruit on a Fixed Term Contract 12 months, a Senior Specialist, Regulatory Operations reporting to the Associate Director, Regulatory Operations Lead.The Regulatory Operations Senior Specialist supports regulatory operations activities within External Manufacturing to ensure that the manufacture of products by Contract Manufacturing Organizations (CMOs) is aligned with the appropriate regulatory dossiers. The role provides quality and compliance support to Quality Operations.Key Duties and Responsibilities:Provide regulatory operations support for External Manufacturing to ensure alignment with regulatory dossiers   Support compilation and maintenance of Regulatory Restriction Forms (RRFs) and batch restriction tracking. Coordinate communication of Market approvals to CMOs via the Regulatory Restriction process.Support regulatory documentation for filings, updates, renewals, and HA requests, including CMC review and submission supportWrite, review, and maintain regulatory, GMP, and Reg Ops procedures and documentation; support site procedure review and approvalSupport progression of GMP documents within the Documentation Management SystemTrack and support timely closure of regulatory actions and Change Controls, working with Virtual Plant Teams (VPTs)Maintain regulatory trackers and ensure data accuracySupport preparation of regulatory inputs and summaries for APQRsProvide GMP/regulatory support, including training and inspection readiness; participate in audits, inspections, and quality risk activitiesCollaborate with Quality Operations, Regulatory Affairs, and CMOs on compliance activitiesParticipate in cross‑functional meetings, projects, and ExM initiatives, including Quality Culture and Operational ExcellenceProvide general team support, including presentations, meeting minutes, and other administrative activities, as requiredQualifications, Knowledge and Skills Required:Demonstrates understanding of international regulatory requirements for new market authorisations and post‑approval activitiesWorking knowledge of External Manufacturing business processesEffective communication and collaboration skillsUnderstanding of current Good Manufacturing Practice (cGMP) principles for Active Pharmaceutical Ingredients (API) and Drug Product manufactureWorking knowledge of FDA, ICH, and BMS corporate cGMP policies and guidelinesAbility to support cross‑functional activities and manage tasks to meet timelines and deadlinesStrong technical writing and documentation skillsAttention to detail with a focus on data accuracy and complianceAbility to adapt to change and be receptive to new ideasBachelor’s degree (or equivalent) in a scientific discipline.Experience within the pharmaceutical industry, ideally in Quality, Manufacturing Technology, Regulatory Affairs/Sciences, or within a Health Authority or regulatory agency.Demonstrated knowledge of pharmaceutical manufacturing and quality systems, including Quality Control, Quality Assurance, and Regulatory Affairs/Sciences.Experience interacting with Health Authorities, including supporting regulatory inspections, is desirable.Proven experience working with external manufacturers and supporting quality activities at external manufacturing sites.Why you should applyYou will help patients in their fight against serious diseases You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.BMSBL#LI-Hybrid If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical t