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Regulatory Affairs Specialist

hace 21 horas


l'hospitalet de llobregat, España BD A tiempo completo

Job Description Summary Being a key strategic partner for the EMEA BD Business by (i) supporting the implementation of registration/regulatory strategies for the UCC–SRG portfolios, closely aligned with the region's commercial objectives, to meet EMEA market requirements and (ii) securing local markets by maintaining local licenses compliant with changes related to local/global regulations or changes to the product(s). Responsibilities Drive alignment between regional regulatory strategies and Business Unit and Country RA objectives within BD’s matrix organization. Prepare and compile registration and/or notification dossiers in collaboration with BU and Country RA teams to support timely submissions and renewals. Lead registration planning and prioritization activities in EMEA to ensure strong alignment with business goals. Execute product launch plans, renewals, and amendments, ensuring adherence to regulatory requirements and approved eIPPRA submissions. Conduct impact assessments for product and regulatory changes within EMEA to ensure continued compliance for medical devices and pharmaceutical products. Maintain Regulatory Information Management (RIM) systems, internal registration databases, and tracking tools to ensure data accuracy and transparency. Preferred Requirements Scientific educational background preferred. 5–10 years of Regulatory Affairs experience, ideally across both Pharmaceutical and Medical Device sectors, with international exposure. Strong organizational, planning, and prioritization skills with the ability to manage multiple tasks. Excellent verbal and written communication skills, with the ability to work cross‑functionally and across cultures. High attention to detail with a focus on accuracy and completeness in all regulatory deliverables. Fluent, native‑level English proficiency; computer‑literate and comfortable working in an international environment. Primary Work Location: FRA Grenoble; Additional Locations: ESP Barcelona, ESP San Agustin del Guadalix Salary Range: €36,400.00 - €58,225.00 EUR Annual 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. #J-18808-Ljbffr