Descripción de la oferta
We are looking for a Senior Regulatory Affairs Specialist to join our regulatory team either in France (Eybens) 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.
Salary Range Information
€40,700.00 - €73,300.00 EUR Annual
Primary Work Location: ESP San Agustin del Guadalix
Employment type: Full-time
Job function: Legal
Industries: Medical Equipment Manufacturing
The salary or hourly rate offered to a successful candidate is determined by experience, education, skills, and applicable labor laws and collective bargaining agreements.
BD 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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