Job Information
Sanofi Group Product Manager for Chemistry Manufacturing & Control (CMC) - Biologics and Vaccines in Budapest, Hungary
Location: Budapest
Flexible working: 60% home, 40% office
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.
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?
Join us as Product Manager for Chemistry Manufacturing & Control (CMC) - Biologics and Vaccines and you will play a critical role in support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed and clinical biologic products. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams. You will be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and that regulatory submissions are on time and with high quality. Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management, also provide support for other CMC projects.
Main Responsibilities:
New applications for biologics:
Plan/Prep/Submit/Review support for product dossiers
CTA / IND preparation and maintenance
License Maintenance:
Recurrent filings: annual reports (US, Canadian NDC and YBPR, license and renewals)
Site renewals (ex. Japan Accreditation)
Post Approval Supplements:
Regulatory strategy development
Preparing / Authoring / Review of Submissions – US, EU and Rest of World (ROW)
Technical Review of site supporting documents (CoA, declarations, SMF, MBR, SOPs)
Notify Reg Ops for publishing and dispatch
Response to Queries – US, EU and ROW
Interaction / liaise with EMA and EU member state on CMC topics
Change Controls:
Change control assessments
Initiate change in regulatory database and follow-up with local regulatory representatives on the assessments of the change
Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations
About you
Experience:
+3 years regulatory experience or relevant industry experience
Manufacturing, QA/QC experience
Previous experience working in a fast-paced , matrix environment on multiple product lines
Biological products, vaccines or small molecules experience is preferred
Soft skills:
Excellent organizational and communication (written and verbal) skills
Demonstrated ability to work successfully on project teams
Technical skills:
Knowledge of FDA/EMA regulations is preferred
Proficient in MS Word, Excel, PowerPoint, MS Project
Education:
Minimum Bachelor’s degree in Life Sciences or related or equivalent
RAC certification is desirable but not essential
Languages:
- Strong command of spoken and written English is mandatory
Why choose us?
Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
Work from an "Office of the Year 2023" award winner with flexible home office policy
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)
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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
Discover our Code of Conduct (https://www.codeofconduct.sanofi/) , that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.
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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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)