Responsable Affaires Réglementaires (CDD 6 mois) in Rueil Malmaison, France

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us .

Contrat à Durée Déterminée 6 mois

Rattaché au Directeur Associé Affaires Réglementaires Oncologie, vous réaliserez les activités liées aux missions du département Affaires Réglementaires en France, dans le respect des dispositions du Code de la Santé Publique, des lois françaises et internationales, de la Charte de l’information promotionnelle et des procédures internes en vigueur.

Plus précisément, vous interviendrez sur :

• La publicité ; vous vérifierez et approuverez les documents promotionnels et les supports de formation de la visite médicale en conformité avec la réglementation et vous vous assurerez du dépôt des dossiers de demande de visa publicité dans les délais requis. Notamment dans le cadre de lancement de produits.

• La pharmacovigilance et la gestion des risques ; vous préparerez et mettrez à jour les outils de minimisation des risques des produits dont vous aurez la charge. Vous collaborerez également avec les équipes de Pharmacovigilance Internes ces produits.

• Vous serez également impliqué dans le suivi de l’enregistrement des produits , en collaboration avec les équipes internationales, la validation des articles de conditionnement et les constitutions des dossiers de transparence.

• Vous serez également impliqué dans la constitution des dossiers de demandes d’accès précoce, en collaboration avec les équipes internationales et locales.

• Vous serez amené à contribuer à des projets transverses au sein du département, notamment évaluer la faisabilité réglementaire de projets innovants de la BU.

• Vous assurerez un support réglementaire auprès de la Direction Internationale des Affaires Réglementaires pour l’autorisation et le suivi des essais cliniques mise en œuvre par BMS ou en collaboration avec des promoteurs institutionnels.

Profil et compétences recherchés

• Pharmacien, spécialisation en Affaires Réglementaires

• Au moins 1 ans d’expérience réussie en Affaires Réglementaires, de préférence au sein de laboratoires de produits innovants.

• Aisance à travaille en équipe

• Esprit positif et constructif

• Capacités d’adaptation

• Force de proposition

• Anglais professionnel

• Maîtrise du pack Microsoft Office

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated 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 a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

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.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1582131

Updated: 2024-06-05 02:55:16.855 UTC

Location: Rueil-Malmaison-FRA

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.