Expiry Date: 14-12-2020
Category Regulatory Affairs
Job Type: Full Time
** Global Regulatory Lifecycle Lead ** Director or Associate Director ** RTP/North Carolina with Relocation Offered
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, Latin 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 press the red “Apply for position”, or contact Theo Moore or Matt Greig on US toll free 855.505.1382.
We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380 or US 855.505.1382.
GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.