Regulatory Affairs Manager, Europe Biologic SME
IQVIA · Bucuresti, Romania
RegulatoryFull-timeCompany career page
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Role summary
IQVIA seeks an experienced Regulatory Affairs professional to provide expertise on European biologic product applications and lifecycle management. The role involves managing complex regulatory submissions, supporting post-marketing activities, and serving as a trusted advisor across multiple regulatory procedures.
What they're looking for
- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or related scientific field
- Minimum 8 years of Regulatory Affairs experience
- Strong expertise in European regulatory requirements, procedures, and submission pathways
- Proven experience with biologic products and post-marketing regulatory activities
- Knowledge of lifecycle management, variations, renewals, and maintenance activities
- Experience with labelling updates and CMC-related regulatory activities
- Excellent communication and stakeholder management abilities
What you'll be doing
- Provide regulatory expertise for European market applications and post-marketing activities across product lifecycle
- Prepare, coordinate, and review regulatory submissions including applications, variations, and labelling updates
- Support regulatory strategies and activities across Centralised, Decentralised, Mutual Recognition, and national procedures
- Serve as subject matter expert on post-marketing activities, renewals, and maintenance for biologic products
- Identify regulatory risks and collaborate with cross-functional teams including CMC, clinical, and quality stakeholders
Privacy & handoff
This role links to IQVIA's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.