Regulatory Affairs Manager

IQVIA is The Human Data Science Company. We use data, technology, analytics and human ingenuity to help healthcare clients deliver better solutions for patients and drive healthcare forward.

Why this role, why IQVIA?
Join our Regulatory Affairs and Drug Development Solutions organization, where technology enabled regulatory services reduce time, cost, and risk across the product lifecycle, from early development through submissions and post registration. You will lead global strategy and execution that streamlines pathways, mitigates regulatory risk, and improves the probability of approval, supported by IQVIA’s worldwide footprint and digital capabilities.

The opportunity
We are seeking a Regulatory Affairs Manager with proven Global Regulatory Lead experience to drive global regulatory strategies and submissions for human medicinal products. You will own the regulatory roadmap, and coordinate worldwide filings across major agencies including EMA and FDA, partnering closely with CMC, Labeling, Publishing, Clinical and Safety teams.

Key responsibilities

• Lead as Global Regulatory Lead for assigned assets, set the global regulatory strategy and act as the primary point of contact to cross functional teams and governance bodies
• Plan and deliver submissions across major regions, including initial marketing authorizations and lifecycle activities such as variations, renewals, line extensions and labeling updates
• Own health authority interactions, prepare briefing packages, coordinate scientific advice and meetings, and drive risk based mitigation plans
• Integrate technology enabled operations, partnering with Regulatory Publishing and RIM and labeling workflows to maximize speed and quality, including eCTD, structured labeling, CCDS and Target Product Profile
• Steward lifecycle management, oversee post approval maintenance, market expansions, withdrawals, market authorization transfers, and compliance monitoring across regions
• Represent IQVIA standards in stakeholder communications and client meetings, aligning to our employer branding guidance and templates

Qualifications

• Bachelor’s or Master’s degree in Life Sciences or related field
• Eight or more years in Regulatory Affairs, including two or more years in a Global Regulatory Lead capacity driving global strategies
• Demonstrated success with EMA and FDA submissions and post approval lifecycle management including variations, renewals and labeling
• Experience collaborating across CMC, Labeling, Publishing, Pharmacovigilance, Clinical and local Regulatory Affairs affiliates, with comfort using eCTD and labeling workflows
• Strong communication skills in English, as well as additional European language
• Ability to operate independently in a fast paced, matrixed environment, balancing strategic oversight with hands on delivery

What we offer

• An opportunity to shape global regulatory pathways with data driven insight and world class technology to accelerate patient access
• Flexible and tailored approaches and a global network that empowers impact at scale
• Career growth within a diverse and inclusive team that thrives on bold ideas and innovation

Ready to drive global regulatory strategy?
Apply now and join a team where your potential has no limits.

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

The potential base pay range for this role, when annualized, is 185 300,00 zł - 344 300,00 zł. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.