Senior Regulatory Affairs Specialist BD
is one of the largest integral medical technology companies. The Senior Regulatory Affairs Specialist will ensure regulatory compliance of products and services for assigned countries (France – Eybens (38) or Spain – San Agustin del Guadalix), maintain alignment with authorities, customers, and internal stakeholders, contribute to strategic regulatory analysis, monitor developments and provide insights to leadership.
Responsibilities
Contribute to international regulatory submission strategies (excluding US).
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 a 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; able to work with both specialists and non‑specialists.
Capable of managing multiple projects within deadlines and working collaboratively in cross‑functional teams.
Benefits At BD you will have the opportunity to learn, grow, and thrive in an inclusive culture. Compensation and benefits information is available on our Careers Site.
Salary Range €40,700.00 – €73,300.00 EUR Annual
Equal Opportunity Statement 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.
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