Expiry Date: 16-11-2021
Categories Biotech, Regulatory Affairs
Job Type: Full Time
US Regulatory Lead ** Step-up Global Director role ** Relo / hybrid ** NJ/PA/NYC area
Note: this role can be based from 2 R&D sites, 1 in greater NYC, 1 in NJ/PA borders; you can hybrid up to 50% of the time. A very decent relocation is available dependent upon your individual situation; it is well-/fully funded and includes house purchase or rent to rent if needed.
About My Client
This is a well-known, stable and solid top 10 Bio-/PharmaCo (they have many well-known, marketed products in mAbs, small molecule and also new modalities). This role reports to an early development Executive Director, and supports translation medicines development, adaptive regulatory strategy, Pre-IND and EOP1/2 meetings, for the US (primarily) as well as other core development markets (EU, China, Japan, Canada).
This organization are well-known for innovation, ability to quickly ratchet-up clinical development and for their strength of in commercialization – they have several well-known brands in each therapy area. Although the company is large, the teams are not, and they maintain strong connections between each project teams and the regulatory team overall. The line manager is highly knowledgeable, a eulogist, Regulatory is a key partner in the development process with Clin Sci and Clin Dev.
About The Role
Please NOTE: We are looking for US FDA Liaison experience, prior global is useful, but FDA subs and HA meetings is the main expertise you will bring. Prior Oncology experience is desirable but not necessary.
This is a regulatory strategy role, so we are seeking someone who has an interest in disease-state / MOAs biology, not just regulatory, in an area where you will enjoy intellectually absorbing data, shaping thinking, looking for innovation or creativity, and help the global project team identify development indications and lead how the CDP and Prots are translated into the overall regulatory strategy (with agency buy-in as required!). As the US is much more adaptive, it is your US experience we are seeking, you will gain if you do not have it yet, EU and other markets, as this is a global role.
So the role is open to an experienced US Liaison who wants to work in Oncology for their first time (maybe you completed Post Docs in research that are relevant, or have rare or critical disease experience and a strong understanding of immune), or you will have prior Oncology experience and want a global role. Either way my client’s line manager will support you in bringing you upto speed and giving you the mentoring you will want and expect.
About The Package
My client will buyout stock and bonuses for the right person. You will benefit from a decent high end salary, bonus, stock, and soft bens, as well as Friday summer afternoon closing and an unofficial Xmas shutdown. Relocation is very good, and will leave you cash positive. There are kindergartens on-site if needed and subsidized.
To apply, please contact me directly, Matt Greig, on firstname.lastname@example.org or you can call me on 908-332-9157 (including weekends). Alternatively, please press the red “Apply for position” button and follow the registration process.
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