Regulatory Affairs Manager
Regulatory Affairs Manager
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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 Manager EU & Global Markets
Location:Poland or Portugal (Remote/Hybrid)
Language:Fluent English required
We are seeking a seasonedRegulatory Affairs Managerto lead complex regulatory projects and support post-approval lifecycle management for human medicinal products across EU and global markets. This is a strategic individual contributor role requiring at least 8 years of experience in regulatory affairs.
Key Responsibilities
- Act as Regulatory Lead on complex projects including technical writing and strategic planning.
- Independently prepare and review regulatory submissions (notifications renewals variations new applications MAH transfers).
- Lead interactions with Regulatory Agencies and represent the company in regulatory discussions.
- Provide guidance and mentorship to junior colleagues and contribute to their development.
- Draft and review regulatory SOPs and ensure alignment with current standards.
- Collaborate with client regional heads to define and execute regulatory publishing and submission strategies.
- Monitor project budgets and timelines ensuring high-quality deliverables.
Qualifications
- Bachelors or Masters degree in Life Sciences or related field.
- Minimum 8 years of experience in EU regulatory affairs with proven leadership in lifecycle management.
- Fluent in English (C1 or above).
- Deep knowledge of EU regulatory procedures intelligence and CMC requirements.
- Strong project management and stakeholder engagement skills.
- Experience in regulatory strategy development and documentation planning.
- Proficiency in Microsoft Office and regulatory publishing tools.
- Ability to thrive in a dynamic fast-changing 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:
Manager
Employment Type
Full-Time
