Expiry Date: 26-12-2021
Categories Biotech, Regulatory Affairs
Job Type: Full Time
New York County
Location: New York Metropolitan area
About My Client
My team and I would describe this organization as a leading 5 Star Bio-/Pharma organization with a strong and diverse pipeline in a number of different therapy areas, including the hiring TA which is in Cardio-Vascular - they are looking for 2 regulatory senior managers / scientists ready to now join at the Associate Director grade in a role where the US Liaison and Global strategy role is combined for a number of high-profile Cardiovascular NMEs with multiple indications.
My client’s Cardio-Vascular portfolio can easily be described as being wide and diverse, and has approx. 20 indications in development with existing global blockbusters in market ($8 Billion in sales).
You will be working from the Global HQ across a global regulatory matrix and platform and be supported in the other regions, with visibility for key stakeholder relationships within the franchise. You will be assigned to one of several highly prized assists still in development or in new lifecycle submissions, as a Regulatory Strategic leader and US Liaison.
About Your Experience
You will have either worked on Cardio, Respiratory or a similar disease area and be interested in continuing in this therapy area, on ground-breaking NMEs with distinct MOAs. You will have already supported US IND / IND amendments, or sBLA or sNDA or first filing NDA or BLA filings, and now want more responsibility for leading your own indications or filings, under the support of an experienced Vice President with a strong track record of their own.
You will know you want to learn and develop, and be willing to get involved with the teams, and enhance existing strategy and develop new plans and strategies as data becomes available. You will have already tasted this type of activity and want to grow more in this area.
You will have a strong understanding of the US regulatory framework and maybe some exposure to the European regulatory pathways (you will be supported by EU Liaisons).
I think the main point of this type of role is you will have already worked on submissions either in development or for lifecycle and now want to expand your experience and through merit take on more responsibility in a step-wise manner.
Package & Location
On offer is a very strong package (rated as one of the best in the industry) and includes a high basic, bonus and stock plan, that vests yearly. For the right candidate, my client will also buy-out any loss of bonus for 2022, or any vesting stock you are likely to receive over the next 2 years!
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