Regulatory Affairs Manager
Milan, Italy Permanent Date posted Oct. 23, 2024Regulatory Affairs Manager
- Location: Milan
- Job type: Permanent; full time
About the job
Our Team:
The Italian Regulatory Affairs department provides strategic and technical advice at the highest level in the company. In this way, the team make a significant contribution, both commercially and scientifically, to the success of a development programs.
Main responsibilities:
- Provide to GRA input for marketed products and contribute on the efficient preparation of the regulatory submission and/or any type of responses document to Health Authority questions in strict cooperation with GRA and other functions (Medical, Pharmacovigilance, etc.).
- Ensure maintenance and compliance of regulatory activities for existing products.
- Ensure that Marketing Authorizations, product packaging and associated information are updated in accordance with the current product licenses and in line with new safety information in a timely manner and inspection readiness.
- Ensure quality and compliance of local regulatory activities in line with corporate regulatory affairs, national and European regulations.
- Highlight compliance issues with all products within the portfolio and make proposals for their resolution.
- Maintain a good relationship cooperating with all the other Company functions.
- Follow regulatory changes and assess potential impact on daily activities
- Develop a comprehensive understanding and interpretation of the EU/national regulatory requirements.
- Pro-actively review new legislation and guidance documents, share them with RA Lead and Country RA Team.
- Develop relationships with the local Regulatory Authorities to facilitate activities required to meet the needs of the business.
- Ensure efficient and practical support for promotional and non-promotional materials activities in compliance with local regulation guidelines and internal guidelines.
About you
Experience: significant and proven experience in Regulatory Affairs.
Soft skills: flexibility, resilience, active learning, coordination skills, reading comprehension, team working, problem solving.
Technical skills: Regulatory knowledge, analytical skills, time management, presentation skills, write-right.
Education: Scientific Degree.
Languages: Fluent Italian and English – written and speaking.
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, 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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Developing
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