Senior Specialist, Regulatory Affairs, CMC

Lavipharm

Senior Specialist in Regulatory Affairs ensuring compliance with CMC requirements for pharmaceutical products in Greece. Collaborating with R&D, Quality, and Operations teams to support product registration.

Posted 6/11/2026full-timePaiania • 🇬🇷 GreeceSeniorWebsite

About the role

Key responsibilities & impact

Evaluate the technical documentation and prepare the technical dossier for different categories of products [i.e. CMC writing and Compilation of Common Technical Document (CTD) Module 3 and Module 2.3 (Quality Overall Summary), required for registration of new pharmaceutical products or variation & renewal applications for existing products], under minimum supervision
Maintain current knowledge of relevant regulations, including proposed and final rules
Implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained
Ensure compliance with the company’s policies and procedures
Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities
Work with specialist computer software and resources of the pharmaceutical products/raw material
Communicate with all departments to ensure and provides properly and effectively any CMC regulatory support as required.
Co-ordinate with R&D, Quality and Operations teams to ensure compliance to the relevant guidelines

Requirements

What you’ll need

BSc in a relevant area is required. Master of Science Degree (M.Sc.) is optional
3-5 years Regulatory Affairs experience in CMC RA Department of a pharmaceutical company
Excellent Knowledge of the Greek & English language
Computer literacy

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Lavipharm Website LinkedIn All Job Openings 201 - 500 employees Established in 1911, Lavipharm is today an integrated Group engaged in Research and Development, Marketing and Sales, Distribution and Wholesaling of pharmaceutical, cosmetic and healthcare products in Greece, with a strong international activity. Senior Specialist, Regulatory Affairs, CMC 🔥 5 minutes ago 🏢🏡 Paiania – Hybrid ⏰ Full Time 🟠 Senior 🚔 Compliance Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Evaluate the technical documentation and prepare the technical dossier for different categories of products [i.e. CMC writing and Compilation of Common Technical Document (CTD) Module 3 and Module 2.3 (Quality Overall Summary), required for registration of new pharmaceutical products or variation & renewal applications for existing products], under minimum supervision
Maintain current knowledge of relevant regulations, including proposed and final rules
Implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained
Ensure compliance with the company’s policies and procedures
Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities
Work with specialist computer software and resources of the pharmaceutical products/raw material
Communicate with all departments to ensure and provides properly and effectively any CMC regulatory support as required.
Co-ordinate with R&D, Quality and Operations teams to ensure compliance to the relevant guidelines 🎯 Requirements
BSc in a relevant area is required. Master of Science Degree (M.Sc.) is optional
3-5 years Regulatory Affairs experience in CMC RA Department of a pharmaceutical company
Excellent Knowledge of the Greek & English language
Computer literacy Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

CMC writingCommon Technical Document (CTD)regulatory complianceregulatory affairstechnical documentationregulatory databasesfiling systemspharmaceutical productsquality overall summaryregulatory support

Soft Skills

communicationcoordinationorganizational skillsattention to detailproblem-solving

Certifications

BSc in relevant areaMaster of Science Degree (M.Sc.)