IQVIA
Regulatory Affairs Manager, Europe Biologic SME
Romania · Work style not stated · Full time
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About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerIQVIA
- LocationRomania
- Work styleWork style not stated
- Employment typeFull time
- Employer posted
At IQVIA, our Global Regulatory Affairs team partners with pharmaceutical and biotechnology companies worldwide to navigate complex regulatory environments and accelerate access to innovative therapies.
We are seeking an experienced Regulatory Affairs professional with deep expertise in European regulatory affairs and biologic products. This role is ideal for a senior regulatory specialist who enjoys managing complex market applications, lifecycle management activities and post-marketing submissions while acting as a trusted advisor to customers and internal stakeholders.
What You'll Do
- 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 activities, labelling updates and CMC-related variations.
- Support regulatory activities across Centralised, Decentralised, Mutual Recognition and national procedures.
- Identify regulatory risks and provide practical recommendations to support successful project delivery.
- Serve as a subject matter expert for post-marketing regulatory activities, including variations, renewals, maintenance activities and labelling changes.
- Collaborate closely with CMC, clinical, safety, quality, labelling and project management stakeholders.
- Participate in customer interactions, project meetings and governance discussions, providing clear regulatory guidance and recommendations.
- Support continuous improvement initiatives and contribute to high-quality regulatory delivery across global programmes.
- Ensure regulatory deliverables meet required quality, compliance and timeline expectations.
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What We're Looking For
- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry or another relevant scientific discipline.
- At least 8 years of Regulatory Affairs experience.
- Strong expertise in European regulatory requirements, procedures and submission pathways.
- Proven experience supporting or managing market applications and post-marketing regulatory 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 within a matrixed and client-focused environment.
- Excellent communication and stakeholder management skills.
Additional Experience That Will Help You Stand Out
- Experience supporting complex European regulatory procedures.
- Broad exposure to CMC regulatory activities.
- Experience working within a CRO, consultancy or outsourced services environment.
- Experience partnering with global cross-functional teams.
- Customer-facing regulatory experience.
- Experience supporting multiple products, markets or regulatory programmes simultaneously.
Why IQVIA?
Joining IQVIA means becoming part of a global team of regulatory experts supporting the development and lifecycle management of medicines that improve patient outcomes around the world.
In this role, you'll have the opportunity to:
- Build deep expertise in biologics and European regulatory affairs.
- Work on complex regulatory programmes across multiple markets.
- Partner with leading pharmaceutical and biotechnology companies.
- Collaborate with global experts across regulatory, quality, safety, clinical and CMC functions.
- Contribute to innovative regulatory solutions in a highly collaborative environment.
- Progress toward Associate Director, senior SME and broader Global Regulatory Affairs leadership opportunities.
If you are passionate about European Regulatory Affairs, biologics and lifecycle management, we'd love to hear from you.
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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At a glance
- Employment typeFull time
- Employer posted
- Added to ROLIVA
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Skills in this posting
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