Expiry Date: 28-05-2021
Category Regulatory Affairs
Job Type: Full Time
New York County
Regulatory Leader ** Are you a US Regulatory Liaison step up to GRL ** Early or Late Stage Roles: Top 5, NJ or NYC or Remote
Location: NJ, NYC Remote Now .. Relocate Later
You may be a US RL or an existing GRL and want to focus on early development or join a 2B/3A/B program, for a set of indications on an existing blockbuster! You will be mentored and grown by one of two senior regulatory heads, both have track records gained from working in more than 1 continent so have both US and EU direct expertise to help nurture you when necessary!
Note on Location / Relocation & Covid! My client is offering a stay in place and digital hiring process, until Summer 2021. My role can be based in one of two locations, one is near NYC, the other New Jersey / PA borders. If you are top notch, they will consider remote for longer for the right candidate!
This role is assigned to me, Matt Greig, you can contact me on US 908-332-9157 - I do take calls on Saturday and Sunday AMs (US time), as well as normal hours!
About the Role & Company
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.
Skills & Experience
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 aimed at 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 to draw upon Oncology demands.
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 comes with a top level relocation package, for both house buyers and renters if needed post Covid. The campuses have subsidized nurseries, and relocation can be suspended until Summer 21 if needed.
My client is willing for the right person to buy out stock plans, and provide a set of incentives and sign on’s 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.
They offer Summer Friday Half Days and an extra Xmas lockdown (the latter is non contractual) on top of normal holidays, way better than average Health Insurance, decent stock plan with shorter vesting, and decent bonuses based on both company and personal performance.
This role is assigned to me, Matt Greig, you can contact me on US 908-332-9157 - I do take calls on Saturday and Sunday AMs (US time), as well as normal hours! Alternatively, please send a full CV to me, at email@example.com and I will reply by return. Alternatively, please press the red “Apply for position” button and follow the registration process.
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