Description
At DEMO S.A., one of the world’s leading pharmaceutical manufacturers in injectable facilities, we are looking for experienced Regulatory Affairs Professionals to join our team. We welcome Senior Professional profiles with expertise in either or both of the following areas: pre-approval operations, including the preparation and management of new marketing authorization submissions, and post-approval operations, including variations, renewals, regulatory updates, and lifecycle management of approved products. The positions are based in Kryoneri, Attica.
Responsibilities:
- Lead, coordinate, or support regulatory activities related to new submissions, variations, renewals, and lifecycle management, depending on experience and seniority level.
- Prepare, review, compile, and submit high-quality regulatory documentation in line with applicable requirements and timelines.
- Manage regulatory submissions through DCP, MRP, and National procedures, ensuring quality and on-time delivery.
- Act as a key liaison with Regulatory Authorities and coordinate responses to questions or deficiencies.
- Drive cross-functional input for dossier compilation, working closely with internal departments and external partners.
- Support regulatory strategy for assigned products, markets, or projects, ensuring alignment with business priorities and compliance standards.
- Monitor and manage post-approval regulatory activities, including variations, renewals, regulatory updates, and lifecycle management activities.
- Review regulatory documentation and scientific responses to ensure accuracy, consistency, and compliance.
- For supervisory and managerial roles, guide, coach, and develop team members while ensuring effective prioritization and delivery of regulatory projects.
Requirements
- BSc or MSc degree in Chemistry, Biology, Pharmacy, Life Sciences, or a relevant scientific field
- Solid experience in Regulatory Affairs within the pharmaceutical industry, preferably
- Experience level may range from senior professional to supervisor or manager, depending on the role and background
- Good knowledge of regulatory requirements, guidelines, and submission procedures
- Strong organizational skills, attention to detail, and ability to manage multiple priorities and deadlines
- Excellent communication and stakeholder management skills
- Fluency in English and good command of MS Office tools
- For people-management roles, proven ability to coordinate, motivate, and develop team members will be considered an asset
Benefits
The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.