Job details

Regulatory Manager

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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)

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 our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

#LI-EUR

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

What You Should Know About Regulatory Manager, Sanofi

Are you ready to take the lead as a Regulatory Manager at Sanofi in beautiful Athens, Greece? This is an amazing opportunity to shape the future of medicine while working in a hybrid environment—spending 60% of your time in our vibrant office and the rest from the comfort of your own space. As a Regulatory Affairs Manager, you'll play a key role in ensuring the registration and maintenance of marketing authorizations for our medicinal products. Your expertise will guide our teams through the complexities of drug development, making a real impact for patients and their families. Your day-to-day responsibilities will include preparing and updating necessary documentation for product registrations, monitoring stages of registration processes, and communicating with national authorities to ensure compliance with both local and global regulations. Not only will you oversee Cyprus registrations, but you'll also participate in important projects by identifying regulatory risks and opportunities, all while collaborating with our global teams. If you have 3-5 years of experience in Regulatory Affairs within the pharmaceutical sector, and hold a relevant degree in life sciences, we'd love for you to come on board. This role demands analytical skills, precise communication, and a collaborative spirit as you work closely with stakeholders to ensure that our products reach the people who need them. Join us at Sanofi, and let's pursue progress and discover extraordinary results together!

Frequently Asked Questions (FAQs) for Regulatory Manager Role at Sanofi

What are the main responsibilities of a Regulatory Manager at Sanofi?

As a Regulatory Manager at Sanofi, you will take on significant responsibilities including the submission and maintenance of documentation for medicinal product registration. You will communicate with national authorities, oversee the registration process, manage licenses, and ensure compliance with both EU and local legislation.