Regulatory Affairs Manager

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 seasoned Regulatory Affairs Manager to 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

• Bachelor’s or Master’s 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 https://jobs.iqvia.com