Regulatory Affairs Specialist
il y a 6 jours
Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled Regulatory Affairs Specialist to join our team in France.
About the RoleAs a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and guidelines in France. You will work closely with our cross-functional teams to develop and implement regulatory strategies that support the launch of new products.
Key Responsibilities- Verify and approve promotional materials and training documents for medical visits in compliance with regulations.
- Prepare and update risk minimization tools for products under your responsibility, collaborating with internal Pharmacovigilance teams.
- Contribute to the monitoring of, in collaboration with international teams, the validation of packaging articles, and the constitution of transparency dossiers.
- Support regulatory affairs activities for the Direction Internationale des Affaires Réglementaires, including authorization and monitoring of clinical trials implemented by BMS or in collaboration with institutional sponsors.
- Pharmacist with specialization in Regulatory Affairs.
- At least 1 year of successful experience in Regulatory Affairs, preferably in innovative product laboratories.
- Ability to work in a team.
- Positive and constructive attitude.
- Adaptability.
- Proposal skills.
- Professional English.
- Microsoft Office skills.
Bristol Myers Squibb offers a unique and inclusive work environment that promotes diversity in clinical trials. Our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.
We are committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request reasonable accommodations/adjustments in completing this application or in any part of the recruitment process.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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il y a 6 jours
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