Expiry Date: 01-07-2020
Categories Biotech, R & D, Regulatory Affairs
Job Type: Full Time
Regulatory Leader ** Are you currently a US Regulatory Leader / Liaison step up to GRL ** Multiple Major Indications in Oncology (Solid Tumour)
Location: PA, USA
You may be a US RL or an existing GRL and want to join a 2B/3 program, for a set of indications on an existing blockbuster! You will be mentored and grown by a senior regulatory head, with a decent track record gained in more than 1 continent, so they have RA expertise gained from developing both US and EU strategies, this is a high value program in a highly-visible organization!
This role is assigned to me, Matt Greig, you can contact me on US toll free 855.505.1382 or within Europe call +447918679405 - I do take calls on Saturday and Sunday AMs (US time), as well as normal office hours!
We are pleased to be giving you this opportunity, which we would think would fit well with an up and coming Associate RA Director or an existing Regulatory Director who wants to jump in on a set of clinical programs with each having a decent probabilities of success! You will be mentored and coached by a set of senior leaders with substantial Oncology RA expertise, in a company which is tipped for the top, as they are running more than >100 registration studies in this TA group, with a pipeline which has depth and breadth, and with a R&D spend which means everything can be run in parallel.
The role is a GRL position but if you have already led or co-led US NDAs or BLAs, or new indications in the USA in solid tumour this role is still open to you! Alternatively you might be a GRL in an your existing role but feel you would like to join a late stage programme or perhaps you are feeling your program is under-funded or under prioritized, either way I would welcome your call.
At the team level, you will display likeability and have a personality which people will be drawn to, combined with the type of scientific insights Oncology demands. At a management level, you will have definitely started to matrix manage or mentor juniors, and want the potential to grow into a team leader in time in your next opportunity.
You will have worked closely with clinical science, to help share strategies and have a track record in submissions, have prepared and led HA meetings (if you are in a hierarchical company, this could be something you supported), responses to the FDA or EMA, and know how to develop the right regulatory narrative for the projects you have worked on or within submissions.
The role is based in PA, NJ area but you could reach their offices from some parts of NY State and they do offer 3 days in and 2 days out of office, if you want to commute in from Maryland.
The role comes with a top level relocation package, and my client is willing for the right person to buy out stock plans, and provide a set of incentives around role and package which will stand you in good stead and give you a the type of jump start a major move should bring to you.
This role is assigned to me, Matt Greig, you can contact me on US toll free 855.505.1382 or within Europe call +44 7918679405 - I do take calls on Saturday and Sunday AMs (US time), as well as normal office hours!
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