Are you passionate about regulatory strategy and ready to play a central role in shaping the future of pharmaceutical development? A growing and innovation-driven pharmaceutical company is seeking a skilled and proactive Regulatory Affairs Manager to lead the preparation and coordination of regulatory activities across its expanding product portfolio.
This position offers the opportunity to work in a collaborative environment with a strong pipeline of therapeutic solutions. You will be responsible for driving regulatory excellence and supporting product lifecycle management with strategic insight.
Main Responsibilities
- Provide expert regulatory input and compile key elements of regulatory submissions, including Modules 1, 2, and 3 of the Common Technical Document (CTD).
- Coordinate the preparation and timely submission of regulatory applications in compliance with applicable EU legislation and guidelines.
- Serve as the primary liaison with health authorities, managing communication, responding to questions, and facilitating the process of scientific advice.
- Contribute to regulatory strategy during product development and post-marketing phases, aligning regulatory objectives with overall business goals.
- Build and maintain productive relationships with regulatory bodies to ensure efficient review and approval processes.
Candidate Profile
Required Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
- A Master’s degree in Pharmaceutical Sciences, Regulatory Affairs, or Industrial Pharmacy will be considered a strong asset.
Professional Experience
- Minimum of 3 years’ experience in Regulatory Affairs, with proven expertise in EU regulatory submissions and procedures.
- Familiarity with the preparation of full CTD dossiers and the regulatory lifecycle of pharmaceutical products.
Key Competencies
- Excellent command of both Greek and English (written and spoken).
- Strong communication and interpersonal skills with the ability to interpret and clearly present regulatory and scientific information.
- Highly organized, with the ability to manage multiple tasks and meet tight deadlines.
Why Apply
This is a unique opportunity to take ownership of regulatory pathways for innovative products and make a meaningful impact on patient access to high-quality therapies. You will join a passionate team committed to scientific excellence and regulatory compliance in a fast-evolving industry.
What’s Offered
- Gross monthly salary of €3,000
- Private health insurance
- Meal vouchers / Subsidized lunch allowance
- Exposure to innovative, international R&D projects in the generic and value-added space
- Collaborative, science-driven environment with growth potential