# Senior Regulatory Affairs Specialist

**Company**: IQVIA
**Location**: Paris
**Experience**: senior
**Job type**: contract
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Paris-France/Senior-Regulatory-Affairs-Specialist_R1556847?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_a96496a9-cfa

## Description

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 with possibility to convert into permanent contract.

**Responsibilities**

- 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.

**Requirements**

- 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 Management activities, 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.

## Skills

### Required
- Regulatory Affairs
- Pharmacy
- Life Sciences
- French
- English
- MS Office

### Nice to have
- regulatory information management systems
- artwork review tools

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