Regulatory Manager
Athens, Greece Permanent Posted on Mar. 28, 2025 Closing on Apr. 22, 2025- Location: Athens, Greece
- Hybrid: 60% office based, 40% remote
- Job type: Permanent, Full-time
About the job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join us as Regulatory Affairs Manager and you’ll be responsible for the registration and maintenance of marketing authorizations for medicinal products within your assigned portfolio. This includes leading the registration, renewal, and post-authorization variation processes, as well as handling procedures for medical devices when needed. You will oversee Cyprus registrations, ensuring compliance with both global and local requirements.
Main responsibilities:
Registration Responsibilities:
- Prepare, submit, and update documentation for medicinal product registration.
- Communicate with national authorities to meet legal obligations.
- Collaborate with Global Regulatory Affairs.
- Monitor and follow up on registration stages.
- Check and correct official documents.
- Align registration activities with company strategy.
- Optimize portfolio by managing licenses and MA discontinuation.
- Participate in DHPC letters process.
- Act as backup for Regulatory manager.
Registration Projects:
- Identify and assess regulatory opportunities and risks.
- Verify project document data for accuracy.
- Prepare comments and suggestions.
- Cooperate with company headquarters and stakeholders.
- Deliver regulatory data for pipeline.
- Provide support at product launch stage.
- Ensure continuous availability of products.
- Monitor competitor activities.
Legislation and Guidelines:
- Analyze legislative changes and their impact.
- Evaluate documents for new guidance and draft legislation.
- Consult relevant authorities.
Internal and Global Procedures:
- Draft internal procedures and perform training.
- Manage updates of Product Information texts.
- Enter regulatory data in databases and perform QC.
Promotional Materials:
- Evaluate and approve promotional materials.
- Provide regulatory support for promotional activities.
Knowledge Sharing:
- Support Country Regulatory Head in process development.
- Implement new work processes and tools.
External Relationships:
- Build and maintain relationships with local Health Authorities.
- Participate in Trade Associations and Professional Societies.
Audit Readiness and Compliance:
- Follow GxP requirements and manage deviations, risks, and changes.
- Report adverse events and quality complaints.
- Act in line with ethical and compliance rules.
- Attend ethics and compliance trainings.
About you
- Experience:
- At least 3-5 years’ experience within Regulatory Affairs or in similar function in the pharmaceutical industry
- Pharmaceutical legislation knowledge (EU and local)
- Soft and Technical skills:
- computer literacy
- decision making ability
- analytical and organizational skills
- precise, good communication
- collaboration
- good organizational skills
- stress-tolerance.
- Education: Bachelor and/or Master’s degree in medicine / pharmacy / biomedical sciences or other relevant life sciences
- Languages: Fluent Greek and excellent knowledge of English language (spoken and written)
PursueProgress. Discover Extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
#LI-EUR
Pursue progress. Discover extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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