Regulatory Affairs Specialist, Europe Submissions iqvia

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.