REGULATORY COMPLIANCE ANALYST H/F

Job description

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people at Sanofi are dedicated to make a difference in patients’ daily life, wherever they live and enable them to enjoy a healthier life.
iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.
PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.
Therefore, only applications that are submitted in English will be considered.
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.
We are looking for a candidate for a VIE mission of:
Regulatory Compliance Analyst
- VIE Contract (W/M)
Key responsibilities:
- Participate in regulatory compliance process
- Participate in change control process, performing or coordinating regulatory assessment and participating or leading the committees as appropriate
- Participate and ensure renewal process
- Coordinate the preparation with the CMO (Contract Manufacturing Operations) and prepare, if necessary, the CMC (Chemistry Manufacturing and Controls) documents for registration in the agencies of the different markets
- Collect and communicate performance indicators
- Generate necessary procedures and quality documents for regulatory processes and their tools according to their experience
- Collaborate in the design of the annual training plan in order to ensure that the appropriate training is provided in their field of competence
Candidate's profile:
- Education: Master degree in Pharmacy, Chemistry or related field
- Experience: at least 1 year of experience in quality or regulatory areas of the pharmaceutical industry
- Soft skills: attention to detail, creativity, team player
- IT tools: MS Office
- Languages: fluent English and at least intermediate Spanish