Regulatory Affairs Manager
Il y a 3 mois
Join Bristol Myers Squibb and Experience a Unique Opportunity
At Bristol Myers Squibb, the work environment is anything but typical. Each day, impactful contributions are made across various departments, from enhancing production processes to pioneering advancements in cell therapy, ultimately affecting the lives of patients and the careers of our employees. You will have the chance to develop and thrive in ways you never thought possible, surrounded by diverse and high-performing teams.
Reporting to the Associate Director of Oncology Regulatory Affairs, you will be responsible for executing regulatory affairs functions in France, ensuring adherence to health regulations and internal protocols.
Your Key Responsibilities Will Include:
- Reviewing and approving promotional materials and training documents for medical visits in accordance with regulations, ensuring prompt submission of advertising visa applications, particularly for new product launches.
- Preparing and revising risk minimization strategies for assigned products, working closely with internal Pharmacovigilance teams.
- Participating in packaging validation, dossier transparency, and early access requests in collaboration with both international and local teams.
- Contributing to regulatory evaluations, assessing the feasibility of innovative projects within the Business Unit.
- Providing regulatory assistance for clinical trial approvals and monitoring, either by BMS or in partnership with institutional sponsors.
Qualifications and Skills Required:
- Pharmacist with a specialization in Regulatory Affairs
- A minimum of 1 year of proven experience in Regulatory Affairs, ideally within innovative product laboratories
- A collaborative team player with a positive and constructive attitude
- Ability to adapt and a proactive mindset
- Professional proficiency in English and strong command of Microsoft Office
Discover Engaging Work and Transformative Careers at Bristol Myers Squibb
At BMS, every employee plays a role in realizing the transformative vision of "Transforming patients' lives through scienceTM". You are empowered to leverage your unique talents in a diverse and inclusive environment, fostering innovation and diversity in clinical trials while upholding shared values.
About Our Work Environment
Bristol Myers Squibb offers a variety of work structures, including site-essential, site-by-design, field-based, and remote-by-design roles. The nature of your position determines the required occupancy type:
Site-essential roles require 100% onsite presence at your designated facility. Site-by-design roles may adopt a hybrid model with at least 50% onsite involvement. Field-based and remote-by-design roles necessitate physical travel as an essential function.
BMS is committed to inclusive employment practices and workplace accommodations, supporting individuals with disabilities and promoting health and safety measures for all employees.
BMS welcomes applicants from diverse backgrounds, including those with arrest and conviction records. We uphold data privacy in accordance with applicable regulations.
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