Regulatory Consultant (Greece) bei Propharmagroup

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Position Overview

ProPharma are seeking a Greek native speaker with proven expertise in regulatory affairs to provide flexible, on-demand post-approval support for one of our clients. This is a 1-year contract role focused on ensuring continuity and compliance in promotional materials review, variations, and related lifecycle management activities.

Key Highlights:

• Contract Duration: 1 year
• Expected Hours: 15-25 hours per month on average (Fluctuations in hours likely)
• Location: Europe
• Language: Greek and English essential  

Responsibilities

• Provide backup support for post-approval regulatory activities, including:
  • Promotional review of marketing materials, claims, and campaigns to ensure compliance with Greek and EU regulations.
  • Preparation and submission of variations to marketing authorisations.
  • Handling ad-hoc regulatory queries, sick leave coverage, and overflow work from the primary FTE RA.
• Collaborate with internal teams to review and approve promotional content in Greek.
• Ensure all activities align with Astellas' quality standards and regulatory timelines.
• Participate in training (provided by Astellas) to maintain alignment with company processes.

Requirements

• Native Greek speaker with fluent English proficiency (written and verbal).
• Minimum 3+ years of experience in regulatory affairs within the pharmaceutical industry, with specific expertise in:
  • Promotional material review and approval.
  • Marketing authorisation variations.
  • Post-approval lifecycle management in Greece/EU.
• Proven ability to work flexibly and independently under varying workloads.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***