Regulatory Affairs Consultant

hace 1 semana

españa Apsida Life Science A tiempo completo

Job Title Regulatory Consultant (EMEA) Contract 12-Month Contract, 0.5 FTE Location Remote (EU-based) About Us Our client is a specialist consultancy supporting emerging and established biotechnology companies in navigating complex regulatory pathways. We work across a diverse range of innovative therapeutic products, helping clients build robust regulatory strategies and achieve successful market authorization. We are seeking an experienced Regulatory Consultant to join our team on a part‑time contract basis. Role Overview The Regulatory Consultant will provide hands‑on leadership and support for Market Authorization Applications (MAA) within the EMEA region, particularly the EU. This is a client‑facing role requiring regular interaction with health authorities and cross‑functional development teams. The successful candidate will have direct experience guiding novel products through late‑stage development and approval, including preparation for Phase III pivotal studies and initial submissions for market authorization. Key Responsibilities Lead, prepare, manage, and support Market Authorization Applications (MAA) for innovative drug products within EMEA markets. Serve as the primary regulatory point of contact for assigned clients, ensuring high‑quality communication and strategic alignment. Develop and maintain regulatory strategies to support successful product approval timelines. Coordinate and prepare regulatory documentation, including module components, scientific briefings, and responses to health authority questions. Represent clients in interactions with Health Authorities (e.g., EMA), including planning, preparing, and participating in regulatory meetings. Provide regulatory guidance on Phase III clinical development programs, ensuring alignment with MAA readiness requirements. Advise cross‑functional teams (clinical, CMC, nonclinical, quality) on regulatory requirements and evolving guidelines. Monitor regulatory landscape developments and communicate relevant changes to clients and internal team members. Required Qualifications & Experience Extensive regulatory affairs experience within the biotechnology or pharmaceutical sector. Proven track record preparing, submitting, and supporting MAAs within the EU/EMEA region. Direct experience representing companies in Health Authority interactions. Experience supporting Phase III studies and leading regulatory planning through late‑stage development. Experience working with products being brought to market for the first time (innovative or novel modalities preferred). Strong client engagement and communication skills, with the ability to influence and advise senior stakeholders. Ability to work independently and manage multiple projects concurrently. Must be based in the EU and legally able to work remotely. Preferred Experience Experience with advanced therapy medicinal products (ATMPs), biologics, or other first‑in‑class product types. Consultancy experience or similar role interfacing with multiple client organizations. How to Apply Please submit your CV along with a brief summary of your relevant regulatory experience and availability. #J-18808-Ljbffr

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