Expiry Date: 01-05-2021
Categories R & D, Regulatory Affairs
Salary: On Application
Job Type: Full Time
USA NC ** Global Regulatory Lifecycle Lead ** Director or Associate Director **
Location: Raleigh, USA
’’It’s all about the lifecycle!’’ Anon.
I am seeking an experienced global RA lead, who enjoys working on complex, lifecycle plans world-wide, and has experience of leading the strategy and filing plans for line extensions (new clinical indications) as well as new dosage forms, for the major markets so US, EU, Japan, China, Canada, ANZ, as well as emerging markets in MENA, LatAm and Asian countries but it is your core markets experience that we want to hire. You might have worked in NME registrations and now want to gain more territory, this is also useful.
The role is to focus on supporting 2 well-known brands, both high patient assets, in CNS but we would consider someone who has experience in parallel markets, where continual Rx prescription is required, such as Respiratory, Diabetes or Renal, or an individual who has a broad spread of therapeutic experiences.
The role is to manage the regions to execute your strategies and those you will inherit, which will include managing a mix of direct affiliates and also vendors. The programmes include a major rollout of 2 major label extensions / new clinical indications for a set of high profile products, generating in excess of 1.5 Billion USD.
You will manage in matrix a group of regulatory professionals and international partners, with the assistance of various vendors and their regulatory teams, this is using a mixed vendor model so expertise with consultancies and regulatory suppliers would be useful.
In return for your expertise, my client offers a strong package including a high performing RSU based stock plan, bonus, competitive package and a full relocation if you require it.
The role can be based in Raleigh, plus another location in the East Coast, and we will share these options with you when we speak.
To apply for this role, please contact me, Matt Greig, on US toll free 855.505.1382 or alternatively, you can email me at firstname.lastname@example.org or register on this website, and I will respond by return.
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