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About the Role
We are seeking an experienced Regulatory Affairs Associate or Senior Regulatory Affairs Associate to join our team! In this role you will be ensuring compliance with Health Authority drug promotion and promotional labeling regulations for assigned licensed products across Europe. This role combines deep regulatory expertise with consulting excellence to deliver high-quality services to our clients while advancing commercial success. You will review, approve, or reject promotional programming based on European regulations and guidance, ensuring adherence to established processes, SOPs, and work instructions.
Working within Parexel's consulting framework, you will provide regulatory leadership while delivering projects that meet both client and Parexel quality expectations. The role can be full remote or office based.
Key Responsibilities
1. Review advertising and promotional labeling materials; comment, improve, approve, or reject content based on company practice, policy, European law, and Health Authority regulations
2. Collaborate with Commercial Operations Marketing, Legal, and Medical personnel to minimize/mitigate Health Authorities enforcement risk while advancing commercial objectives
3. Monitor and apply trends in regulation of advertising and promotional labeling to review practices and processes
4. Provide regulatory leadership and guidance to marketing teams during development, review, and approval of promotional materials for assigned therapeutic areas
5. Prepare and submit advertising and promotional labeling materials to Health Authorities as required
6. Serve as Project Lead for small-scale projects or Work Stream Lead on larger projects
Skills and Experience required for the role:
7. University in a Scientific or Technical Discipline
8. Initial years in Regulatory Affairs relevant industry experience in Advertising & Promotional Labeling (required)
9. Ability to implement regulatory science and monitor enforcement trends
10. Capability to read and comprehend product-related technical and medical information
11. Client-focused approach with results orientation
12. Excellent teamwork and collaboration skills
13. Strong consulting skills with critical thinking and problem-solving abilities
14. Proficiency in English written and spoken