Regulatory Affairs Manager, Europe Biologic SME

About the role

iQVIA's Global Regulatory Affairs team partners with pharmaceutical and biotechnology companies worldwide to navigate complex regulatory environments. It is looking for an experienced Regulatory Affairs professional with deep expertise in European regulatory affairs and biologic products, ideally a senior specialist who manages complex market applications, lifecycle management and post-marketing submissions while advising customers and internal stakeholders.

Key responsibilities

• Provide regulatory expertise for European market applications and post-marketing activities across the product lifecycle.
• Support the development and execution of regulatory strategies for biologic products.
• Prepare, coordinate and review regulatory submissions, including market applications, lifecycle management, labelling updates and CMC-related variations.
• Support activities under Centralised, Decentralised, Mutual Recognition and national procedures.
• Identify regulatory risks and recommend practical solutions to ensure project success.
• Serve as subject matter expert for post-marketing activities such as variations, renewals, maintenance and labelling changes.
• Work closely with CMC, clinical, safety, quality, labelling and project management stakeholders.
• Take part in customer interactions, project meetings and governance discussions, giving clear regulatory guidance.
• Contribute to continuous improvement and ensure deliverables meet quality, compliance and timeline expectations.

Required profile

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or another relevant scientific discipline.
• At least 8 years of Regulatory Affairs experience.
• Proven experience supporting or managing market applications and post-marketing activities across the product lifecycle.
• Strong knowledge of lifecycle management, variations, renewals and maintenance activities.
• Experience managing labelling updates and CMC-related regulatory activities.
• Experience working with biologic products is essential.
• Ability to work independently as a regulatory subject matter expert in a matrixed, client-focused environment.

Required skills

• Strong expertise in European regulatory requirements, procedures and submission pathways.
• Excellent communication and stakeholder management skills.
• Nice to have: complex European regulatory procedures, broad CMC regulatory exposure, CRO or outsourced services experience, global cross-functional teamwork, customer-facing regulatory experience, and experience supporting multiple products or markets at once.

Candidates can progress toward Associate Director, senior SME and broader Global Regulatory Affairs leadership opportunities.