Regulatory Affairs Professional

About the role

DEMO S.A., a leading pharmaceutical manufacturer of injectables, is looking for experienced Regulatory Affairs professionals to join its team in Kryoneri, Attica. The company welcomes senior profiles with expertise in pre-approval operations (new marketing authorisation submissions) and/or post-approval operations (variations, renewals, regulatory updates and lifecycle management).

Key responsibilities

• Lead, coordinate or support regulatory activities for new submissions, variations, renewals and lifecycle management, depending on experience and seniority.
• Prepare, review, compile and submit regulatory documentation in line with requirements and timelines.
• Manage submissions through DCP, MRP and national procedures, ensuring quality and on-time delivery.
• Liaise with regulatory authorities and coordinate responses to questions or deficiencies.
• Contribute to dossier compilation with internal departments and external partners, and support regulatory strategy for assigned products, markets or projects.
• Monitor and manage post-approval activities such as variations, renewals and regulatory updates.
• Review documentation and scientific responses for accuracy, consistency and compliance.
• For supervisory and managerial roles, guide, coach and develop team members.

Required profile

• BSc or MSc in Chemistry, Biology, Pharmacy, Life Sciences or a relevant scientific field.
• Solid experience in Regulatory Affairs within the pharmaceutical industry; experience level ranges from senior professional to supervisor or manager depending on the role.
• Good knowledge of regulatory requirements, guidelines and submission procedures.
• For people-management roles, proven ability to coordinate, motivate and develop team members is an asset.

Required skills

• Strong organisational skills, attention to detail and ability to manage multiple priorities and deadlines.
• Excellent communication and stakeholder management skills.
• Fluent English and good command of MS Office tools.

What we offer

• Competitive salary and benefits.
• Continuous specialised training and career development.
• A friendly working environment.