REGULATORY MANAGER AND TRANSVERSAL PROJECT LEAD, CSE MCO
Budapest, Hungary Permanent Date posted Oct. 18, 2024- Location: Budapest, Hungary
- Hybrid
- 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 our Country Regulatory Team as Regulatory Manager and Transversal Project Lead and you’ll lead transversal regulatory activities within region to standardize processes ensuring alignment across country teams. You will be also responsible for the registration and maintenance of marketing authorizations for medicinal products of assigned portfolio, by leading the registration, renewal and post-authorization variation processes.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main responsibilities:
- Responsible for effective performance of registration, renewal and post-authorization variation processes for assigned portfolio in accordance with the applicable regulations.
- Supervises update of Hungarian Product Information texts in contact with internal stakeholders and with the local Health Authorities.
- Develop and strengthen relationship with Regulatory Authorities responsible for the authorization of medicinal products.
- Manage transversal projects in cooperation with Global Regulatory Affairs. Build strong external network (HAs, Trade Associations, Universities).
- Contribute to implementing of digital projects in collaboration with other regulatory teams.
- Lead transversal regulatory activities within Central and South MCO to standardize processes ensuring alignment across country teams.
- Effectively works with other global functions (such as Medical, PV, Quality, Supply Chain)
- Legislation and Guidelines: Analyze legislative changes, participate in developing new guidance and draft legislation, and lead the drafting of internal procedures.
- Product Labeling and Promotional Materials: Supervise updates to product information and packaging, evaluate promotional materials, and provide regulatory support for promotional activities.
About you
- Experience:
- At least 5 years’ experience within Regulatory Affairs or in similar function in the pharmaceutical industry
- Experience in managing Health Authorities communications.
- Prior professional experience in project management, including planning and executing strategies.
- Managerial and interpersonal skills applied to matrix organization, effective international, cross-cultural collaboration skills.
- Pharmaceutical legislation knowledge (EU and local)
- Experience in managing vaccine portfolio is an advantage.
- Soft and technical skills:
- computer literacy
- decision making ability
- precise, good communication
- collaboration
- good organizational skills
- stress-tolerance.
- Education: Master’s degree in medicine / pharmacy / biomedical sciences or other relevant life sciences
- Languages: English & Hungarian written and spoken.
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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