Expiry Date: 30-09-2021
Categories Biotech, Regulatory Affairs
Job Type: Full Time
Regulatory Scientists & Strategists ** Early or Late Phase Development ** Have strong US, gain Global!
Note: my roles are in 2 East Coast locations, 1 being greater NYC and the other being on the other side of New Jersey near the PA borders. During Covid, all new hires are being interviewed through MS Team, and on-boarded remotely and the offices are closed til late Q1/Q2 next year so home working.
After Covid, a full relocation is offered, and funded if needed and this can be stop watched til Summer 2021. Additionally, post Covid, if you are local but don’t like commuting, my client offers a 50% at home and 50% in office policy!
About My Client
My client, a top 5 company, has 2 great line managers, who have earnt their regulatory stripes, by leading teams to approvals, and have now grown themselves in to line managers. The roles we have are for individuals with 4-6 years in regulatory affairs, that want to work in pure developmental regulatory roles, ie, supporting registrations resulting from clinical studies. We have two different levels of grade going upto and including the Associate Director grade.
You will either lead several NMEs in development for FTIH so Ph 1 then 2, as a strategist, developing initial regulatory strategy with oversight for the global IND filings, PreIND meetings, and EOP1/2 meetings, in a role which is very much focused on the science, so MOA, draft TPP, using regulatory intelligence and internal data, to help create and shape a strategy which could include fast acting 1B Spider / Umbrella studies and then adaptive pathways with some with FTD and / or ODD.
You will lead Ph 3a/3b programs, as a regulatory filing strategist with the support of Senior GRLs and the line manager, to prepare your program for pre-submission, review and day questions, in the USA and also in Europe and the international majors (Japan, China, Canada, etc).
In both roles, you will work in an organization known for having strong processes and systems, outstanding clinical and project team counterparts, as well as formidable CDx, in licensing and development leads and budgets.
Experience & Skills
You will have between 4-6 years’ experience in regulatory but this can include Fellowships and placements in your first years, and have either defined or authored strategy documents or helped by drafting in part regulatory strategy for your assigned molecules. You will have experience in review and submission of at least 3 of the following:- INDs, EOP1/2 and Pre-Submission Meetings Brochures, NDA, or sNDA, ODD, Paediatric Plans or filings, BTD applications.
Package & Benefits
In return, my client offers strong salaries and bonuses for individuals at Manager, Senior Manager, Associate Director grading (we have a certain amount of bandwidth on grading for the Regulatory Strategist role). Additionally, the roles come with Stock (RSU, quicker vesting), Summer Friday Half Days, a Xmas shutdown (latter is non contractual), and a better by far than average Health Insurance and Rx costs scheme.
Note, my client will buyout stock and annual performance for the right candidates!
To apply, please contact either myself Matt Greig on US 908.332.9157 or my colleague Theo Moore on US 855.505.1382 - alternatively please send a full CV to CV@AdvTalent.com and we will reply by return!
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