Expiry Date: 18-06-2020
Categories Biotech, Regulatory Affairs
Salary: On Application
Job Type: Full Time
Executive Regulatory Director ** US regulatory functional management ** Mid Cap Bio-Pharma
This is a great opportunity for an individual who wants to move up from a Therapeutic Head role, to a Head of US role, with a decent sized team in the 30’s FTEs and a mix of both early development, late development, lifecycle, labeling, regulatory policy teams reporting into you.
The regulatory organization functions well, but there are key challenges for the successful incumbent, as the company has now pivoted from a global TA structure, to a regional hierarchy, so this is a newly created role, and the stakeholders will require the engagement, reset and build, for you to deploy your full value you can bring.
Additionally, we are looking for an individual who will be the broad and welcoming face to the FDA, and will regularly attend the FDA meetings, to support the asset leads and commercial leads, the Global Regulatory Leads, for you to be able to bring the best level of consistency and narrative across the NMEs in development (mostly large molecules) as well as any major meetings for Benefit Risk such as Advisory Boards. By being there, you will be able to coach and mentor the teams as you see wise and fit.
Additionally, you will have a track record in your formative years in terms of leading US or global submissions to NDA/BLA or MAAs with approvals, or have managed a pipeline in a molecule type of product with many clinical line extensions.
This role has both breadth and depth, as you will have all except the CMC RA teams, for the region reporting to you, so you will be the senior leader for critical interactions and submissions, including those from therapy regulatory, as well as Labelling and Ad Promo.
However, you have a strong team reporting into you, who are solid and stable, but my client, the global head of RA, wants someone who brings the maximum amount of unity and cohesion to the teams (remembering that the previous structure as led from global).
The role comes with a top end package, including RSUs, health, holidays, insurances as well as a red carpet relocation if required. The organization will buy out stock plans within reason and will also allow some co location if you are willing to be between their 2 US sites and Washington, DC regularly.
To apply, please press the red “Apply for position” button or contact me, Matt Greig on US Direct 908-332-9157 to find out more about that and other opportunities. I also work Saturday and Sunday AMs for this level of role, and would welcome your call outside working hours at the weekends.
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