Senior Regulatory Affairs Specialist

BD; Grenoble; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

A leading global medical technology firm is seeking a Senior Regulatory Affairs Specialist to ensure regulatory compliance for its products. The role involves preparing documentation for authorities, contributing to submission strategies, and managing post-market obligations. Applicants should possess a master’s degree and a minimum of 5 years in the pharmaceutical or medical device fields, with strong regulatory knowledge and communication skills.

Qualifikationen

• Master's degree or higher in life sciences or scientific field required.
• Minimum 5 years of experience in pharmaceutical or medical device industry.
• Strong knowledge of regulatory requirements, especially 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.

Aufgaben

• Contribute to international regulatory submission strategies.
• Prepare and submit documentation to authorities for product registration.
• Compile technical dossiers 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.

Kenntnisse

Regulatory compliance

Regulatory requirements knowledge

Analytical skills

Communication skills

Project management

Fluent English

Ausbildung

Master’s degree in life sciences or scientific field

Jobbeschreibung

Senior Regulatory Affairs Specialist – BD

BD is seeking a Senior Regulatory Affairs Specialist to join our regulatory team in France (Eybens 38) or Spain (San Agustin del Guadalix). The role is responsible for ensuring the regulatory compliance of products and services for the assigned countries, maintaining alignment with authorities, customers, and internal stakeholders, and providing strategic regulatory analysis to leadership.

Responsibilities

• Contribute to international regulatory submission strategies (excluding US), balancing compliance and business priorities.
• Prepare and submit documentation to authorities to register/notify products (pharmaceuticals or combination products), ensuring compliance with global and 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.

Qualifications

• 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.

About BD

BD is one of the largest global medical technology companies. Advancing the world of health™ is our Purpose, and it’s no small feat. We create transformative solutions that turn dreams into possibilities.

Why Join Us?

At BD, you will learn and work alongside inspirational leaders and colleagues who are passionate and committed to fostering an inclusive, growth‑centered, and rewarding culture. We welcome people who see the bigger picture and want to reinvent the future of health. You’ll discover a culture where you can learn, grow, and thrive, and make a difference.

Equal Opportunity Employer

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.

Additional Information

Salary and benefits are competitive and vary by location and experience. For more information, visit https://bd.com/careers.

Job Details

Senior level – Mid‑Senior level. Full‑time. Health Care Provider, Quality Assurance, and Product Management. Industries: Medical Equipment Manufacturing.