Are you a Senior Regulatory Product Manager – next step Global Regulatory Lead (CNS)

Advanced Regulatory ,
London, Greater London
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Are you a Senior Regulatory Product Manager – next step Global Regulatory Lead (CNS) Dear Reader, We have found that many individuals with a strong track record in product lifecycle management, want to work on more development-lead filings, and find their career expectations are often eclipsed. Also many companies reward GRL roles to individuals who have taken molecules to their first filing in Europe, not to the individuals who do the full lifecycle management, file the LEs, Pediatrics and new dosage forms. If this resonates with you, then this role will appeal, because my client specifically has a GRL position open to anyone who has a strong track record in lifecycle management, including LEs (but in a company where the M3 component is done by RA CMC). We are specifically looking for you if you fit comfortably in this area, and am reaching out to you with an exciting opportunity to step up to the position of a Global Regulatory Leader for an approved neurology product with several studies running worldwide to deliver their final clinical and Paediatric indications After this you will rotate to a NME. Reporting to a PL, you will take ownership over the Regulatory strategy of your molecule and work towards the submissions and approvals. In this task you will be supported by a global matrix team and your regulatory sub-team. You will have oversight for all the global Health Agency meetings and interactions as well as for the timely delivery of global clinical and marketing authorization applications. You will have the chance to develop wider skills because you will sit with clinical, access and strategic medical and marketing, allowing for close communication and effective decision-making between your stakeholders. To apply you will most likely have: 7-10 years of experience in Regulatory Affairs for the EU region plus 1 other Filed line extensions in more than 1 region ideally Some experience in HA meetings and a great deal of experience in responding to HA queries Great communication skills and the ability to inspire and motivate your RA sub-team The desire to venture into something new Then you will definitely find this vacancy appealing because it provides: International exposure in more than one ICH region Great working environment located in West London Collaboration with world-class experts in the field of Neurology Generous salary and benefits package, incl. car allowance, bonus, as well as a decent, high-performing stock plan Fast track for further international career development To Apply To apply , please send a full CV to DavidAdvTalent.com , or alternatively, contact David on 44 (0)207 801 3385. We are assigned these roles by our client and will provide you with support throughout the hiring process. About Advanced Search & Our Network Advanced Search , has a network of affiliated companies including ADV Regulatory , and ADV Talent Partners . Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005. Our Regulatory Affairs team know their subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels. Contact us today to see how we can help you make that next career move on 44 (0)207 801 3380 All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.

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