Associate Director ‘Jr’ Global Regulatory Lead ** Oncology ST or Hemo ** NJ, Hybrid 50 / 50

Reference: SMM541

Expiry Date: 03-05-2023

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Mercer County
United States

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Job Description

About our Client

There are many reasons why I find hiring for this client a pleasure. The management team is well-known, successful, and engaging, the pipeline is expansive and well-funded, and they promote people based on merit!

Our client is a top 5 world renowned and successful R&D-based Bio-Pharmaceutical organization based in the NJ area whom we have been supporting US hiring and global for a few years now -  the pipeline has many new NMEs with novel MOAs, and many high value assets in mid and late phase development and in drug-drug combinations.

They are gradually expanding their teams to meet their pipeline and new lifecycle commitments hence they are looking for a Regulatory Affairs Associate Director to support the more senior GRLs in Oncology:

  • Do you want to work for a world class organization under the tutelage a senior leadership team which has filed many, many oncology BLA and supplementals?
  • Do you want to work for a company which has the funds and the money to invest on high value assets quickly and where the regulatory ladder and path to promotion is clear?
  • Do you want to work cheek to cheek with Clinical to develop overall regulatory strategy and have visibility on clinical design in a company where Clin Prot, CODx and Reg Strategy run smoothly side by side?
  • Do you want to work on early phase to learn strategy or late phase to fill sBLA and sNDAs in quick succession?

About the Role

This position is exciting because it will give you the exposure to develop both the global and US regulatory strategies for Oncology products and also through the first round of new indications while co-leading all regulatory interactions.

You will have previous experience co-leading or assisting compilation of submissions such as INDs, PIPs, BTDs or ODDs OR have supported BLA or sBLAs or NDAs or sNDAs.

We are not necessarily looking for a certain number of years but more an aptitude to learn and you will already have had your intellectual baptism in Oncology!

Package & Benefits

They are offering a strong compensation package including very decent basic salary and bonus, RSU stock award and Options as well as decent healthcare and savings benefits. The company have a Christmas lockdown and also half days during the summer months.

Location

The company will consider relocation for the right candidate, but the role is definitely not fully remote, they do require you to spend 50% of your time in the offices which are both in New Jersey!

 

To Apply!

To apply for this role, please contact me, Christian or my colleague Matt Greig on US 908 332 9175 or press the red “Apply for position” button or send a full CV to Christian@AdvTalent.com and we will reply immediately to explain more about our client and the role. We know the hiring manager and the leadership team so we will support you throughout all the interviews and on-boarding process.

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