Regulatory Affairs Manager
About the Opportunity
We have a great opportunity at Ablynx for a Regulatory Affairs Manager.
As Regulatory Affairs Manager, you will support the Global Regulatory Team Lead (GRTL) and you are part of the Global Regulatory Affairs (GRA) organization within the Sanofi Genzyme Global Business Unit (GBU). You will be responsible for developing long and short-term regulatory strategies for the projects and products under your accountability. The Regulatory Affairs Manager is responsible for the development strategies for the assigned project/products.
Ablynx, a Sanofi Company
Ablynx, a Sanofi company, is engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Nanobodies have potential uses in the treatment of a range of serious and life-threatening human diseases. Ablynx advances a portfolio of Nanobody-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology.
- Support the cross functional project team and provides overall regulatory input for the project(s) globally.
- Develop robust global regulatory strategies, including Global Submission Strategy (GSS), for their assigned products and develop and maintain a global regulatory product strategy document (GRPS).
- Work transversally to ensure a properly functional regulatory sub-team. Facilitate the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries.
- Prepare presentation of the global regulatory strategy/position to senior management / governance committees as needed.
- Work with the labelling strategists and regional groups to ensure appropriate labelling content based on the clinical program and TPP. The GRTL will also work with the labelling strategist and regions to develop region specific labels.
- Communicate relevant topics to the business and up through GRA senior Management. The communication of any HA feedback should be interpreted and the impact on the project assessed.
- Research and analyse regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes.
- Ensure compliance with all internal and external requirements and procedures and may suggest. improvement to operating policies/processes, as appropriate.
- May line manage, and/or coach mentor, junior staff supporting the program.
- Depending on the program assignment, may also serve as the EU/US Regulatory Lead.
To excel in this role you will need to have:
- Bachelor degree or higher in a scientific discipline.
- 5+ years in Regulatory Affairs or relevant industry experience.
- Experience working in a multinational environment.
- Strong communication skills.
- Ability to work well within cross-functional teams.
- Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance.
- Attention to detail.
- Fluency in English.
What Sanofi can offer you
This is a role which offers opportunity for development and growth, especially as you are joining a Research Organisation with a strong and innovative pipeline.
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
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