20 meilleures offres (regulatory affairs lead, paris (75)) (à pourvoir)

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Amgen —Paris (75)
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Senior Regulatory Affairs Specialist

IQVIA -
Courbevoie (92)

Soumettre votre candidature

Détails de l'emploi

Temps plein
Il y a 13 jours

Qualifications

Français
Anglais
Microsoft Office
Niveau Licence
Gestion des informations

Description complète du poste

Courbevoie, France | Full time | Home-based | R1556847

Shape the future of regulatory excellence at IQVIA

At IQVIA, we work to advance healthcare by helping our clients bring safe, effective medicines to patients. As a Senior Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance and supporting the full product lifecycle across a diverse portfolio of medicinal products. You will collaborate with leading global pharmaceutical companies, provide regulatory expertise, and contribute to high-quality outcomes that make a real difference to patients and healthcare systems. This is a fixed-term opportunity for 12 months contract.

What you will do

Lead and manage country-level regulatory activities for medicinal products, ensuring compliance with local regulatory requirements.
Prepare, coordinate, and submit regulatory documentation for lifecycle management activities, including variations, renewals, notifications, line extensions, MAH transfers, and new marketing authorization applications.
Act as a key regulatory contact for clients and Health Authorities, providing strategic guidance and driving submissions through successful approval.
Support end-to-end Lifecycle Management activities, ensuring product information and regulatory records remain compliant and up to date.
Review and approve promotional and non-promotional materials in France to ensure compliance with local regulatory requirements, company policies, and applicable industry codes.
Review and approve artwork, labelling updates, and packaging components, ensuring consistency with approved product information.
Monitor changes in local regulatory legislation and assess business impact, providing recommendations and implementing required actions.
Collaborate closely with cross-functional teams, including Medical Affairs, Quality, Commercial, and Global Regulatory teams, to support business objectives and regulatory excellence.
Contribute to process improvement initiatives and share regulatory expertise with internal stakeholders and clients.

What you need to succeed

Bachelor's degree in Pharmacy, Life Sciences, or a related scientific discipline.
Significant experience in Regulatory Affairs within the pharmaceutical industry, including management of post-approval regulatory activities and product lifecycle maintenance.
Strong knowledge of local pharmaceutical legislation, regulatory requirements, and submission procedures.
Experience in Lifecycle Managementactivities, including variations, renewals, labelling updates, and maintenance of marketing authorizations.
Experience reviewing and approving promotional and non-promotional materials in France in accordance with applicable regulatory requirements and industry codes.
Proven ability to manage multiple projects simultaneously while maintaining a high level of accuracy and attention to detail.
Strong stakeholder management, communication, and problem-solving skills.
Ability to work independently while collaborating effectively within global and local teams.
Fluent written and verbal communication skills in both French and English.
Advanced computer skills, including MS Office; experience with regulatory information management systems and artwork review tools is an advantage.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Where you'll work

Home-based

You’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.

Culture

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.

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regulatory affairs lead emplois - paris (75)

Senior Regulatory Affairs Specialist

Head of Global Regulatory Operations

Specialist Care Therapeutic Area, Global Regulatory Affairs and Patient Safety - Temporary

Regulatory Affairs Specialist- Belgian Dutch speaker- Remote

Europe Region Lead, Diversity & Inclusion in Clinical Trials (DICT)

Specialist regulatory affairs and quality assurance for IVD medical devices

Senior Regulatory Affairs Specialist

GRA Device Associate, Medical Devices and Combination Products

Compliance & Corporate Affairs Officer M/F

Director of Medical Affairs, France – Structural Heart (Transcatheter Mitral & Tricuspid)

Associate Director, Quality and Regulatory Compliance

Medical Affairs and HEOR Biostatistics Project Lead

Senior Medical Director, Pipeline Lead, Oncology

Senior Global Medical Affairs Director, Medical Asset Lead, Hematology - Oncology (6 months Fixed Term Contract)

Legal Counsel & Business Affairs - Marketing & BtoC (m/f/d)

Head of Evidence Generation - International Region

Global Lead Buyer – Medical and Scientific

Medical Information Manager - CDD 8 months

Director, Advisory Compliance H / F

Head of European Relations

Je souhaite recevoir la dernière alerte Emploi pour les postes de ce type : regulatory affairs lead (paris (75))

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