Senior Specialist, Regulatory Operations

Senior Specialist, Regulatory Operations

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.

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.

Benefits

• Competitive salary
• Annual bonus
• Pension contribution
• Family health insurance
• 27 days annual leave
• Access to BMS Cruiserath on-site gym
• Life assurance

Equal Employment Opportunity Statement

Visit to access our complete Equal Employment Opportunity statement. 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: 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 Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.