Senior Regulatory Affairs Specialist

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Job Description Summary

We are looking for a Senior Regulatory Affairs Specialist to join our regulatory team either in France (Eybens (38) or Spain (San Agustin Del Guadalix). You will be responsible for ensuring the regulatory compliance of products and services for assigned countries and maintaining alignment with authorities, customers, and internal stakeholders. You will contribute to strategic regulatory analysis, monitor regulatory developments, and provide insights and recommendations to leadership.

Responsibilities

Contribute to international regulatory submission strategies (excluding US), while balancing compliance and business priorities.

Prepare and submit documentation to authorities to register / notify products (pharmaceuticals or combination products), ensuring compliance with global / local regulations.

Compile technical dossiers (e.g., eCTD Module 3 CMC) and manage post-market obligations.

Provide regulatory analysis for product launches and commercial communications.

Lead or support regulatory input for change controls and ensure continuous compliance.

Interact with regulatory authorities and internal partners, including during audits and tenders.

About You

Master's degree or higher in life sciences or scientific field (Pharmacist, Master in Regulatory Affairs).

Minimum 5 years of experience in the pharmaceutical and / or medical device industry.

Strong knowledge of regulatory requirements, particularly related to pharmaceuticals and eCTD submissions.

Fluent in English (spoken and written); additional EU language is a plus.

Strong analytical and communication skills; ability to work with both specialists and non-specialists.

Capable of managing multiple projects within deadlines and working collaboratively in cross-functional teams.

BD is one of the largest global medical technology companies in the world. Advancing the world of healthTM is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a maker of possible with us!

Click on apply if this sounds like you!

Becton, Dickinson and Company is an Equal Opportunity / Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

To learn more about BD visit : https : / / bd.com / careers

Salary range : €40,700.00 - €73,300.00 EUR Annual

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