Job Reference: J5633643
Updated On: 19/08/2020
Status: Now Interviewing
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Director Regulatory Affairs - Combination Products
Role OverviewWe are currently looking for a Director Regulatory Affairs - Combination Products to join a leading Biopharmaceutical company. As the Director Regulatory Affairs - Combination Products you will be the Global Lead for a new Drug-Device combination product. You will be responsible for all global regulatory procedures for the drug development and registration where you will lead strategic development.
This position would suit an experienced Regulatory Professional with hands on knowledge of the overall drug development and registration process as well as knowledge of the development and registration of Medical Devices, ideally combination inhalation products.
This position could be based in Brussels - Belgium or at their site in Atlanta - USA.
Key Duties and ResponsibilitiesYour duties as the Director Regulatory Affairs - Combination Products will be varied however the key duties and responsibilities are as follows:
1. Act as Global Regulatory Lead for a Medical Device and Drug substance combination product where you will develop and lead the Global strategy team to ensure the successful registration of the products to Global markets.
2. Provide leadership to a matrix team and ensure that the strategy is communicated clearly to all sites globally.
3. Use your knowledge drug development, clinical trial submission, product registration, line extension and market expansion to ensure the successful registration and maintenance of the drug - device combination product.
4. Work cross-functionally with senior stakeholders and functional leads to ensure business and product strategy is adhered to and that the successful commercialisation is achieved.
Role RequirementsTo be successful in your application to this exciting opportunity as the Director Regulatory Affairs - Combination Products we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences discipline (e.g. Biology, Pharmacology, Pharmaceutical, Drug Development) in addition to extensive experience in Regulatory Affairs where you have licensed and maintained products to EU or US markets.
2. Proven industry experience in of Global procedures and registration where you have worked on drug development, CTAs, product registration, line extension and life cycle maintenance projects.
3. A working knowledge and practical experience with Combination products where you have register a drug-device product to regional or global markets. Experience of inhalation products would be beneficial.
Key Words: Regulatory Affairs | Global Regulatory Lead | Director Regulatory Affairs | Combination Products | Medical Device | Drug-Device | Strategy | Development | Leadership | Drug Development
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