Regulatory Affairs Manager
il y a 6 jours
Join Our Team
At Bristol Myers Squibb, we believe in making a difference. Our work is not just about meeting expectations; it’s about exceeding them. Here, you will engage in impactful projects that contribute to the health and well-being of patients worldwide. Collaborate with diverse teams and embrace opportunities that will challenge you and foster your professional growth.
Role Overview:
Reporting to the Deputy Director of Regulatory Affairs in Hematology, you will be responsible for executing the activities related to the Regulatory Affairs, Quality Assurance & Compliance department in France, ensuring adherence to the Public Health Code, French and international laws, promotional information charter, and internal procedures.
Your 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 assigned products and collaborating with internal Pharmacovigilance teams.
- Participating in the oversight of packaging validation and transparency documentation in collaboration with international teams.
- 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 partnership with institutional sponsors.
Qualifications and Skills:
- Pharmacist with a specialization in Regulatory Affairs.
- A minimum of 1 year of successful experience in Regulatory Affairs, preferably within innovative product laboratories.
- Strong teamwork skills.
- Positive and constructive mindset.
- Adaptability and flexibility.
- Proactive approach to problem-solving.
- Professional proficiency in English.
- Proficient in Microsoft Office Suite.
Transforming Lives Through Science
At BMS, we are committed to fostering an inclusive culture that values diversity and empowers every employee to contribute their unique talents. Our shared values of passion, innovation, urgency, accountability, inclusion, and integrity drive us to achieve our mission.
Work Environment
Bristol Myers Squibb has a flexible work structure that accommodates various roles, including site-essential, hybrid, field-based, and remote positions. The nature of your role will determine your work arrangement.
Commitment to Accessibility
BMS is dedicated to ensuring that individuals with disabilities can thrive through a transparent recruitment process and reasonable workplace accommodations. We encourage applicants to reach out for any necessary adjustments during the application process.
Health and Safety
We prioritize the health and safety of our employees and the communities we serve. BMS strongly recommends that all employees stay up to date with vaccinations, including Covid-19 boosters.
Equal Opportunity Employment
BMS is an equal opportunity employer, considering qualified applicants regardless of arrest and conviction records, in accordance with applicable laws.
All data processed during the application process will be handled in accordance with relevant data privacy policies and regulations.
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