(Senior) Regulatory Affairs Associate - Advertising & Promotional Labeling (home or office based)
This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Spain, United Kingdom, Czechia, Italy, Croatia, Serbia, Oregon (USA) When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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
- Review advertising and promotional labeling materials; comment, improve, approve, or reject content based on company practice, policy, European law, and Health Authority regulations
- Collaborate with Commercial Operations Marketing, Legal, and Medical personnel to minimize/mitigate Health Authorities enforcement risk while advancing commercial objectives
- Monitor and apply trends in regulation of advertising and promotional labeling to review practices and processes
- Provide regulatory leadership and guidance to marketing teams during development, review, and approval of promotional materials for assigned therapeutic areas
- Prepare and submit advertising and promotional labeling materials to Health Authorities as required
- Serve as Project Lead for small-scale projects or Work Stream Lead on larger projects
Skills and Experience required for the role:
- University in a Scientific or Technical Discipline
- Initial years in Regulatory Affairs relevant industry experience in Advertising & Promotional Labeling (required)
- Ability to implement regulatory science and monitor enforcement trends
- Capability to read and comprehend product-related technical and medical information
- Client-focused approach with results orientation
- Excellent teamwork and collaboration skills
- Strong consulting skills with critical thinking and problem-solving abilities
- Proficiency in English written and spoken
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