Senior Specialist, Regulatory Operations

Working with Us
Challenging. 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 Ireland

Bristol 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/ie

The Role

BMS 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 support
• Write, review, and maintain regulatory, GMP, and Reg Ops procedures and documentation; support site procedure review and approval
• Support progression of GMP documents within the Documentation Management System
• Track and support timely closure of regulatory actions and Change Controls, working with Virtual Plant Teams (VPTs)
• Maintain regulatory trackers and ensure data accuracy
• Support preparation of regulatory inputs and summaries for APQRs
• Provide GMP/regulatory support, including training and inspection readiness; participate in audits, inspections, and quality risk activities
• Collaborate with Quality Operations, Regulatory Affairs, and CMOs on compliance activities
• Participate in cross‑functional meetings, projects, and ExM initiatives, including Quality Culture and Operational Excellence
• Provide general team support, including presentations, meeting minutes, and other administrative activities, as required

Qualifications, Knowledge and Skills Required:

• Demonstrates understanding of international regulatory requirements for new market authorisations and post‑approval activities
• Working knowledge of External Manufacturing business processes
• Effective communication and collaboration skills
• Understanding of current Good Manufacturing Practice (cGMP) principles for Active Pharmaceutical Ingredients (API) and Drug Product manufacture
• Working knowledge of FDA, ICH, and BMS corporate cGMP policies and guidelines
• Ability to support cross‑functional activities and manage tasks to meet timelines and deadlines
• Strong technical writing and documentation skills
• Attention to detail with a focus on data accuracy and compliance
• Ability to adapt to change and be receptive to new ideas
• Bachelor’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 apply

• You 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 Careers
With 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 trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [email protected]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.