Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Job Description
IQVIA is The Human Data Science Company focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles IQVIA offers a broad range of solutions that harness advances in healthcare information technology analytics and human ingenuity to drive healthcare forward.
Regulatory Affairs Specialist EU & Global Markets
Location:Poland or Portugal (Remote/Hybrid)
Language:Fluent English required
Join our dynamic Lifecycle Management team as aRegulatory Affairs Specialistsupporting post-approval regulatory activities for human medicinal products across the EU and global markets. This is an individual contributor role ideal for professionals with at least 4 years of experience in EU regulatory affairs.
Key Responsibilities
- Collaborate with local teams to prepare and submit regulatory documents (notifications renewals variations new applications MAH transfers) to local Health Authorities.
- Support the regulatory approval process and ensure compliance with local and international requirements.
- Draft high-quality regulatory and technical documentation with minimal supervision.
- Build and maintain strong relationships with internal stakeholders and external partners.
- Contribute to the development and revision of regulatory SOPs.
- Participate in meetings with Regulatory Agencies and support communication strategies.
Qualifications
- Bachelors or Masters degree in Life Sciences or related field.
- Minimum 4 years of experience in post-approval regulatory affairs for the EU market.
- Fluent in English (C1 or above).
- Solid understanding of the R&D process (especially CMC) EU regulatory guidelines and submission procedures.
- Strong organizational and time management skills.
- Proficiency in Microsoft Office and regulatory publishing tools.
- Ability to work independently and adapt in a fast-paced environment.
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
Required Experience:
Unclear Seniority
Employment Type
Full-Time
