Regulatory Affairs Specialist, Europe Submissions

Are you ready to make an impact in global regulatory affairs? We’re seeking talented professionals with at least 2 years of experience in EU/EMA or US-FDA submissions (Pharma/Biologics) to join a long-term project supporting regulatory lifecycle management for human medicinal products.

As A Regulatory Affairs Specialist / Submission Manager, You Will:

• Support the Global Regulatory Lead (GRL) in preparing core submission dossiers and Module 1 documents (cover letters, forms, DocTocs, etc.).
• Manage submissions across EU markets (EMA CP, CH, DE, FR, UK) and potentially global markets (US, CA, AUS, CIS).
• Execute lifecycle maintenance activities including renewals, CMC variations, safety reports, and labeling updates.
• Liaise with publishing teams and cross-functional stakeholders (Local RA, CMC, Labeling).
• Maintain regulatory databases, SharePoint, compliance systems, and trackers.
• Ensure timely responses to Health Authority queries and conduct QC reviews of submission deliverables.

Required Experience & Technical Skills

• Degree in Life Sciences or equivalent (e.g., Pharmaceutical Science).
• Minimum 2 years’ experience in international regulatory lifecycle maintenance for marketed products.
• Hands-on experience with EU regulatory procedures (variations, renewals, aggregate reports).
• Exposure to new MAA applications in Europe and/or emerging markets.
• Understanding of pharmacovigilance for marketed products.
• Proven ability to manage regulatory projects and interact with Health Authorities.
• Experience preparing CTD documents (especially Module 1) in collaboration with technical experts.
• Quality review of regulatory documents and SOPs.
• Mentorship and training of junior colleagues.

Soft Skills That Set You Apart

• Exceptional verbal and written communication in English.
• Strong organizational skills and ability to manage workload peaks independently.
• Deadline-driven with excellent prioritization and follow-up.
• Collaborative team player with cultural awareness and adaptability.
• Skilled negotiator with a proactive, solution-oriented mindset.
• Proficient in MS Office and document management systems.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com