Medical and Regulatory Affairs
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.
Responsible for all regulatory activities related to assigned products and projects in the role as Regulatory Sciences Manager The Netherlands. Support the Lead GRS The Netherlands.
Reporting to the Lead GRS The Netherlands, manages the daily regulatory activities in Belgium & Luxembourg acquiring and increasing a working knowledge and understanding of BMS products and regulatory processes.
- Manage regulatory processes in line with business/R&D objectives to ensure timely registration of new products/line extensions and variation applications of BMS products.
- Liaise with the Regulatory Agencies in The Netherlands for assigned products.
- Responsible for assuring that approved labelling (SmPC, PL, pack) is implemented in production in accordance with local legislation and BMS procedures
- Monitor and lead the implementation of solutions to changes in legislation and Heath Authority processes.
- Work with local Medical, Marketing, Market Access, Quality and Global Labeling to ensure that regulatory aspects of labeling comply with local legislation and BMS requirements.
- Provide strategic input into product labeling texts (SmPC/PIL) and qualitative review of labelling materials in local language(s), ensuring compliant implementation.
- Responsible for regulatory translations for Benelux and coordination of translations in country (as applicable).
- Oversee the submission of variation applications and approvals for nationally approved products in The Netherlands.
- Responsible for Drug Safety related GRS tasks as per Drug Safety BMS procedures (DHPC, aRMA) and in collaboration with local Drug Safety.
- Responsible for filing clinical trial applications to the competent regulatory authorities in The Netherlands, and all following interactions, in line with BMS company policies and practices, the European Clinical Trial Directive (and subsequent CTR) and local legislation.
- Support the approval process of Early Access Programs (Compassionate use/Medical need programs) and having thorough understanding of required EAP legislation and processes
- Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases.
- Support local projects, regulatory and department related assignments.
- Act as the key GRS partner for the assigned therapeutic area with the country Business functions, Medical function, Clinical Operations function, Market Access function and Quality function.
- Support launch activities and provide key pre-launch support.
- Responsible for the review and approval of Advertising & Promotional materials in The Netherlands as per the local legislative framework and Ethical Code, and BMS´s procedural documents.
- Support reimbursement processes to ensure timely negotiations and approvals in accordance with business objectives.
- Support development and maintenance of the Benelux Regulatory QMS. Create and update local procedural documents.
- Keep up to date with the regulatory environment within the industry.
- Develop the necessary external contacts with e.g. Health Authorities, Regulatory Agencies and building a key network with Trade Associations.
- Establishes and maintains co-operative working relationships with peers and co-workers.
- Contribute to a high performing organisation and culture by developing and performing in a strong regulatory team.
- Continues to upgrade experience by participating in BMS sponsored training to develop technical skills, communication effectiveness and leadership potential.
- Science degree, preferably medical, pharmaceutical or other life science
- Experience in (local) regulatory affairs in a multinational pharmaceutical company
- Experience or very good understanding of the registration process of pharmaceuticals in the EU or BeNeLux
- Knowledge of Good Practices (GMP, GDP, GCP) and quality systems used during stages of manufacture, testing, release, transportations and storage of medicinal products.
- Experience in working with senior regulatory affairs staff on a full range of regulatory tasks.
- Pays strict attention to detail and accuracy whilst maintaining a sense of urgency. Strives to maintain a high level of quality.
- Demonstrated ability in planning, problem solving and time management
- Demonstrated ability in working in a matrix organization and influencing of people in cross-functional teams
- Demonstrated ability in acting as a credible, influential spokesperson in working with senior staff and with peers in related functions.
- Understanding of BMS business processes and working practices
- Fundamental knowledge of BMS product portfolio
- Ability of independent scientific thought, and the capacity to learn and understand new scientific concepts and ideas
- Fluent in Dutch and English.
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.