Expiry Date: 26-09-2020
Category Regulatory Affairs
Job Type: Full Time
Are you a Senior Regulatory Product Manager – next step Global Regulatory Lead (CNS)
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:
Then you will definitely find this vacancy appealing because it provides:
If this sounds like an opportunity you want to explore, then please press the red “Apply for position”, or contact me, Matt, on +44 (0)207 801 3386 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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