Expiry Date: 31-03-2021
Categories Biotech, Regulatory Affairs
Job Type: Full Time
Regulatory Strategist ** Do you have US or Global RA? ** Cardio - Metabolic - Respiratory?
Note: A full relocation for house purchase or house renting is available during or after Covid, next summer, and my client can hire you and bring you on-board remotely for now. After Covid, there is a 50 50 split on time for home and office working policy, so if you live in CT, NYC, PA, or MA and do not want to move fully, this co locate option might work for you.
My client is a tried and tested top 10 pharmaceutical company, successful, ethical, innovative, based in New Jersey. The line manager has a long track history of managing strategists, developing strategists, and gaining directly in her formative years, and through the team, a string of regulatory approvals. The line manager offers a lot of pragmatic expertise to her team to draw upon, for a group which is aligned therapeutically, and covering <> 8 NMEs mostly in late phase development, with both first filing and new indications in Ph 3 studies.
This role offers variety, you will most likely work on two or so programs in parallel, and be interested in working in a company where clinical and regulatory rely on each other, to define new clinical study programs, collaborate on protocols, aligned through health authority meetings, risk mitigation, and then pivotal study design to readout, pre submission and filings!
If you want to work in a regulatory team where their late phase NMEs have a probability of success to file, then this could be a great start for you, the role will be working with molecules with compelling data, and there is enough in the pipeline for the company to achieve potentially a number of approvals in the next two or so years.
Regulatory Strategists that want to achieve a milestone approval, will be interested in this opportunity.
Your Experience & Skills
You will have either focused on US regulatory strategy for early or mid-phase development, and now want to stretch to a NDA or sNDA filing, and grow into a Global role. Alternatively, you might be working as a US Liaison and want to step up into a global role. Equally, you might be assisting or acting as a GRL right now, in any phase of development, and just feel your current program or pipeline may take too long to file (CV studies with MACE are rarely short registration studies, but my client’s Ph 3s are near to readout) or the data is patchy.
We would also consider individuals working in CROs or Consultancies but on ODDs or supporting full NDAs or sNDAs.
In any of the above we would like to hear from you!
Package & Benefits
In return, my client offers strong salaries and bonuses for individuals at Senior Manager, Associate Director and 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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