Manager, Regulatory Compliance

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. 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 a Manager, Regulatory Compliance on a fixed -term contract. Reporting to the Senior Manager, Regulatory Compliance, the Manager, Regulatory Compliance is responsible for all regulatory support activities within External Manufacturing to ensure that the manufacture of products by Contract Manufacturing Organizations (CMOs) is aligned with the appropriate regulatory dossiers. Key Duties and Responsibilities: Manage Operations Manage appropriate business processes to support Regulatory Dossier Management for products supported by External Manufacturing Manage the notification of Change Control approvals and regulatory renewals to CMOs as appropriate, to ensure that the CMO has the most up-to-date regulatory dossiers Manage a process to ensure appropriate batch restrictions are applied in the case of change controls where regulatory approvals are required Manage regulatory documentation requests to support filings, updates, annual reports renewals and Health Authority (HA) requests. Review relevant Chemistry, Manufacturing and Controls (CMC) sections of new drug applications (NDA’s) and market authorisation applications (MAAs) and provide support for filings Provide Good Manufacturing Practice (GMP) and Regulatory training as required Support Regulatory inspections of External Manufacturing Manage the follow-up and close out of regulatory actions associated with External Manufacturing (ExM) Change Controls Designee Responsibilities This position can be a designee for the Senior Manager, Regulatory Compliance Contingency Support Senior Regulatory Compliance Specialist Regulatory Compliance Manager Qualifications, Knowledge and Skills Required: In addition to the core Bristol Myers Squibb (BMS) competencies, the Regulatory Compliance Manager will have following competencies: In-depth understanding of the International Regulatory Requirements post-approval Business Knowledge/understanding of External Manufacturing. Leadership and Management Skills Excellent communication skills Understanding of current Good Manufacturing Practice (cGMP) principles pertaining to Active Pharmaceutical Ingredients (API) and Drug Product pharmaceutical manufacture Demonstrates expert knowledge of Food and Drug Administration (FDA), International Council of Harmonisation (ICH) and BMS corporate cGMP policies and guidelines Ability to manage cross functional projects and meet tight timelines/deadlines Strong Technical writing ability Openness to change, receptive to new ideas BSc / MSc in chemistry or related disciplines Preferable to have 5 years’ experience in Quality Assurance (QA) and 2 years in a regulatory environment. Knowledge / appreciation of other site operations such as Quality Control (QC), Materials, Manufacturing Technology (MT) and manufacturing What’s important to us Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases: Passion: Our dedication to learning and excellence helps us to deliver exceptional results. Innovation: We pursue disruptive and bold solutions for patients. Urgency: We move together with speed and quality because patients are waiting. Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments. Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues. Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential. We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve. 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, 23.5 days annual leave plus 3 Company days, access to BMS Cruiserath on-site gym, life assurance and gain-sharing bonus. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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.