Regulatory Affairs CMC Officer

3 days ago

Athens, Attica, Greece Demo S.A. Full time €25,000 - €40,000 per year

DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, is currently looking for a talented Regulatory Affairs CMC Officer to join our team in Athens (Kryoneri). This position reports directly to the Regulatory Affairs CMC Manager.

Main duties and responsibilities: 

  • Understanding of Regulatory strategy and documentation requirements
  • Act as responsible Regulatory Team member for assigned regulatory projects
  • Prepare, review, and maintain CMC documentation for regulatory submissions in Europe and rest of the world (ROW)  ensuring compliance with current GMP, ICH, and other relevant regulatory guidelines.
  • Prepare and coordinate responses to Deficiency Letters (DLs) and other CMC-related regulatory queries in collaboration with cross-functional teams.
  • Liaise with with R&D, QA, Regulatory Affairs, and Manufacturing teams to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration
  • Liaise with external Regulatory authorities as required
  • Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products

Requirements

  • BSc Degree in Chemistry, Pharmacy,  Biology or relevant field.
  • More than 3 years of experience in Regulatory Affairs / CMC within a Pharmaceutical organization
  • Knowledge of CMC and global regulatory guidelines
  • Fluency in English and good use of MS Office skills
  • Strong organization skills, multi-tasking and able to meet deadlines
  • Effective communication and relationship management
  • Ability to work under pressure, resilience

Benefits

The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.

  • Regulatory Affairs CMC Officer

    23 hours ago

    Athens, Attica, Greece DEMO AΒΕΕ Full time €25,000 - €40,000 per year

    Regulatory Affairs CMC OfficerDEMO AΒΕΕΑΚΟΛΟΥΘΗΣΕ Φαρμακευτικές & Κλάδος ΥγείαςΠροβολή 11 θέσεωνΑθήναΤοποθεσίαΑθήναπριν 3 μέρεςΗμ. ανάρτησηςπριν 3 μέρεςEntry / ΑρχάριοςΕπίπεδο εμπειρίαςEntry / ΑρχάριοςΠλήρης...

  • Regulatory Affairs CMC Senior Officer

    1 week ago

    Athens, Attica, Greece DEMO AΒΕΕ Full time €25,000 - €50,000 per year

    Regulatory Affairs CMC Senior OfficerDEMO AΒΕΕΑΚΟΛΟΥΘΗΣΕ Φαρμακευτικές & Κλάδος ΥγείαςΠροβολή 19 θέσεωνΑθήναΤοποθεσίαΑθήναπριν μία μέραΗμ. ανάρτησηςπριν μία μέραΜε κάποια εμπειρίαΕπίπεδο εμπειρίαςΜε κάποια...

  • Regulatory Affairs CMC Senior Officer

    1 week ago

    Athens, Attica, Greece Demo S.A. Full time €30,000 - €50,000 per year

    DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, is currently looking for a talented Regulatory Affairs CMC Senior Officer to join our team in Athens (Kryoneri). This position reports directly to the Regulatory Affairs CMC Manager.Main duties and responsibilities:Understanding of Regulatory strategy and documentation...

  • Regulatory Affairs Pre-approval Officer

    3 days ago

    Athens, Attica, Greece DEMO AΒΕΕ Full time €40,000 - €60,000 per year

    Regulatory Affairs Pre-approval OfficerDEMO AΒΕΕΑΚΟΛΟΥΘΗΣΕ Φαρμακευτικές & Κλάδος ΥγείαςΠροβολή 11 θέσεωνΑθήναΤοποθεσίαΑθήναπριν 14 μέρεςΗμ. ανάρτησηςπριν 14 μέρεςΜε κάποια εμπειρίαΕπίπεδο εμπειρίαςΜε κάποια...

  • Regulatory Affairs Senior Officer

    3 days ago

    Athens, Attica, Greece Pharmathen Full time €40,000 - €80,000 per year

    DescriptionFounded in 1969, Pharmathen has grown to become one of the largest, vertically integrated developers of complex drug delivery technologies and is among the top 50 pharmaceutical research companies in Europe.The company has one of the most extensive and advanced pipelines of long acting injectables (LAI), sustained release and ophthalmic...

  • CMC Scientist – Pre Approval

    2 weeks ago

    Athens, Attica, Greece PharOS Ltd Full time €40,000 - €80,000 per year

    Founded in Athens in 2002, PharOS is a privately-owned pharmaceutical Company, developing and supplying generics value added products with a global portfolio. Our expertise covers all aspects of product development from API sourcing up to market release. We provide a broad portfolio of products and intellectual property to leading pharmaceutical companies.At...

  • Government Affairs: Internship Opportunities

    3 days ago

    Athens, Attica, Greece Microsoft Full time

    Government Affairs internship for Greece / Cyprus/ Malta & Adriatic'sThe internship is set to begin in January 2026 and will last for a duration of 12 months.Come build community, explore your passions and do your best work at Microsoft with thousands of University interns from every corner of the world. This opportunity will allow you to bring your...

  • Corporate and Government Affairs Manager, Greece

    1 week ago

    Athens, Attica, Greece Mondelēz International Full time €40,000 - €80,000 per year

    Job DescriptionAre You Ready to Make It Happen at Mondelēz International?Join our Mission to Lead the Future of Snacking. Make It Matter.Are you passionate about communications, government affairs and making a positive impact? You will lead all corporate and government affairs activities across Greece and Cyprus (GR & CY) and serve as a key member of the GR...

  • Corporate Affairs Lead

    3 days ago

    Athens, Attica, Greece Ipsen Full time €60,000 - €120,000 per year

    Title:Corporate Affairs LeadCompany:Ipsen Single Member EPEAbout Ipsen:Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of...

  • Regulatory Compliance Officer

    2 weeks ago

    Athens, Attica, Greece Satispay Full time €45,000 - €55,000 per year

    Regulatory Compliance Officer Please note that this opportunity requires relocation to our Luxembourg office. About Satispay Satispay was born to revolutionise everyday payments – making them simple, fair, and accessible to everyone. Now, the focus has moved even further, aiming to shape the future of money. We're a movement empowering millions of...