US Regulatory Lead ** Step-up Global Director role ** Relo / hybrid ** NJ/PA/NYC area (code USA 160921-2)

Reference: MG160921B

Expiry Date: 16-11-2021

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Mercer County
United States

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Job Description

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!

To apply, please contact me directly, Matt Greig, on matt@advtalent.com 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.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number 908-332-9157.

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