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Join to apply for the Regulatory Affairs Specialist role at ESTEVE . Overview Manage the regulatory lifecycle of US FDA‑approved products, ensuring ongoing compliance and supporting regulatory activities for new product development projects. Work closely with cross‑functional teams including Global Regulatory, clinical, pharmacovigilance, and external partners to ensure timely and accurate regulatory submissions and provide strategic input throughout the product lifecycle. Key Responsibilities Prepare, review, and submit FDA documentation, including supplements, annual reports, and amendments. Monitor and interpret changes in FDA regulations and assess impact on existing products. Maintain regulatory compliance for marketed products, including labeling and post‑market surveillance. Collaborate with internal and external stakeholders on transversal projects, providing regulatory recommendations. Support regulatory activities for product development projects, developing regulatory strategies and timelines. Provide general departmental support, including meeting preparations, dossier archiving, RIMS, etc. Qualifications Required Studies: Bachelor’s degree in Life Science, Pharmaceutical Sciences, Biology, or Chemistry. Professional Experience: Minimum 3–5 years in Regulatory Affairs within a pharmaceutical company or CRO. Specialized Knowledge: Strong understanding of US FDA regulatory pathways and guidance documents. Proven experience with FDA submissions. Experience supporting development projects and working with cross‑functional teams. Excellent interpersonal communication skills (written and verbal). Proficiency with PowerPoint, Excel, and Microsoft 365. Languages: Fluent English (required). Spanish (required). Other languages are a plus. Additional Information: Referrals increase your chances of interviewing at ESTEVE by 2x. Seniority level: Mid‑Senior level Employment type: Full‑time Job function: Science Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr
