CMC Product Manager (small molecules)
This role will manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed and clinical products for the Sanofi portfolio. This position will provide input into the product strategy and to the direction provided to commercial and clinical teams.
- Responsible for developing innovative regulatory strategy and assuring this regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality
- Coordinate with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management. Possibility to lead or coach a team of regulatory professionals
- Create collaborative working relationships with Global Regulatory Affairs (scopes: corporate, regional, national), Technical and Quality Groups within R&D and Industrial Affairs, External Alliance Partners, Project Direction/ Management, Regulatory Health Authorities
- Manage new applications for biologics through planning, preparation, submitting, reviewing support for product dossiers
- Lead the license maintenance with annual reports (US, Canadian NDC and YBPR, license and renewals) and site renewals (ex. Japan Accreditation)
- Oversee the regulatory strategy development by ensuring the preparation and review of submissions, the technical review of site supporting documents (CoA, SMF, MBR, SOPs), the notification of Reg Ops for publishing and dispatch to Health Authorities, the interaction with EMA and EU member states BoH on CMC topics
- Evaluate Global Regulatory CMC strategies and risks to develop projects and/or marketed products. Work closely with the CMC teams to achieve implementation of appropriate regulatory strategies with regards to the financial impact and all identified risks
- Strong English knowledge
- Bachelor or ideally Master’s scientific, healthcare or life sciences degree, RAC certification is an asset
- 5+ years of experience in a regulatory function within a matrix environment
- Knowledge and experience of EU, FDA, and global regulations
- Experience with biological products
- IT skills: MS Word, Excel, PowerPoint, MS Project, and Trackwise
- Strong organization and communication skills within a matrixed organization
- Demonstrated ability to effectively influence leaders and team members.
About Sanofi and Global Regulatory Affairs
In 2019 Sanofi Hungary was awarded Top Employer for the 2nd time while the same year Sanofi received the Global Top Employer award the 1st time in history. / while the same year Sanofi became a certified Global Top Employer the 1st time in history.
Sanofi is a global pharmaceutical leader providing healthcare solutions in more than 170 countries around the world. Sanofi has over 100 000 employees representing 145 nationalities worldwide.
At Sanofi’s Global Regulatory Affairs, we’re ushering in a bold new era of regulatory affairs – one that is rooted in collaboration, driven by creativity, and inspired by tomorrow. As strategic partners with our 1.400 RA associated present in over 80 countries, we build regulatory strategies and timely execute our targets while establishing constructive relationships with health authorities and key stakeholders worldwide. We’re harnessing cloud-based systems and advanced technology to amplify the impact of our ambitious teams.
Are you looking for an opportunity to contribute to an agile, global regulatory team? To impact a broad and diverse portfolio of hundreds of products? To drive change at a company that is 100% full-scale all-in committed to transforming its technology base and reimagining the role of regulatory affairs? Apply to join our regulatory Hub and discover all that you can do.”
The offices of Sanofi GRA Hub are in Váci Greens, in the heart of one of Budapest’s most famous business districts. The site offers a comfortable, sustainable and friendly working environment with community areas, gardens and bicycle storage. It is easily accessible by transportation; the site is between Gyöngyösi utca and Forgách utca metro stations.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. 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 colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.