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Regulatory Affairs Lead
Il y a 3 mois
Join Our Team
At Bristol Myers Squibb, we believe in the power of work that is not just ordinary but transformative. Every day, our teams engage in meaningful tasks that significantly impact the lives of patients and the professional journeys of our employees. Here, you will find opportunities for growth and development that are unparalleled, surrounded by a diverse group of high-achieving individuals.
Reporting to the Deputy Director of Regulatory Affairs in Hematology, you will be responsible for executing the functions of the Regulatory Affairs, Quality Assurance & Compliance department in France, adhering to the provisions of the Public Health Code, French and international laws, the Charter of Promotional Information, and our internal procedures.
Your Key Responsibilities Include:
- Reviewing and approving promotional materials and medical training resources in compliance with regulations, ensuring timely submission of advertising visa applications, particularly for product launches.
- Preparing and updating risk minimization tools for the products under your responsibility, collaborating with internal Pharmacovigilance teams.
- Engaging in oversight activities, working alongside international teams to validate packaging articles and compile transparency dossiers.
- Contributing to departmental initiatives, including assessing the regulatory feasibility of innovative projects within the business unit.
- Providing regulatory support to the International Regulatory Affairs team for the authorization and monitoring of clinical trials conducted by BMS or in collaboration with institutional sponsors.
Desired Profile and Skills:
- Degree in Pharmacy with a specialization in Regulatory Affairs.
- A minimum of 1 year of successful experience in Regulatory Affairs, preferably within innovative product laboratories.
- Strong teamwork abilities.
- Positive and constructive mindset.
- Adaptability and flexibility.
- Proactive approach.
- Professional proficiency in English.
- Proficient in Microsoft Office Suite.
Meaningful Work, Transformative Careers
At BMS, our vision of "Transforming patients' lives through scienceTM" empowers every employee to contribute to extraordinary work. We foster an inclusive culture that values diversity in clinical trials, and our core values of passion, innovation, urgency, accountability, inclusion, and integrity drive the potential of our colleagues.
Work Environment
BMS has a diverse work structure that defines where employees perform their duties. This includes site-essential, site-by-design, field-based, and remote-by-design roles. The type of occupancy assigned to you is determined by the responsibilities of your position.
BMS is committed to ensuring that individuals with disabilities can thrive through a transparent recruitment process, reasonable workplace accommodations, and ongoing support in their roles. If you require accommodations during the application process, please reach out for assistance.
BMS prioritizes the health and safety of our employees, customers, patients, and communities. Therefore, we strongly recommend that all employees be fully vaccinated against Covid-19 and stay updated with boosters.
BMS is an equal opportunity employer and will consider qualified applicants with arrest and conviction records, in accordance with applicable laws.
Any data processed during the application process will be handled in accordance with relevant data privacy policies and regulations.
