Expiry Date: 24-12-2021
Category Regulatory Affairs
Job Type: Full Time
About My Client
We are excited to present to you a great opportunity we have with a dynamic and expanding, medium sized Biotech with a great regulatory leadership team (including ex-FDA) and a great pipeline of Immunology and CNS products including Cell and Gene Therapy products in early and mid-stage development.
I would describe this organization as one of my most dynamic clients and they have a fantastic culture which is focused on Regulatory Affairs operating as a true strategic partner with a strong voice in all development teams within both US and Global projects.
Currently we have a senior level Regulatory Affairs US Lead role available where you will be working within their expansive and highly regarded Immunology franchise. The remit is to represent the US Regulatory Affairs as the Science lead in US and Global development plans for early and late-stage development assets in the immunology disease area(s) with the focus on providing regulatory strategic input (in mid or late stage development) and/or leadership for upcoming BLA’s.
You will have co-developed US regulatory strategy and have a good understanding for the US regulatory framework, as well as prepared / submitted at least three of the following: INDs, NDA / sNDA or BLA / sBLAs, Type B or C meetings prep incl. Briefing Brochures or Paediatrics or Safety submissions.
You will have worked with clinical and commercial and have either worked in major lifecycle submissions or in the clinical development phases and want to gain full project lifecycle experience.
Package On Offer
On offer is a great package including a very competitive Salary + Bonus + Stock + Healthcare, and my client will cover any loss of bonus for 2022 on joining and also any loss of vesting stock for the 2022 and 2023 for the right person. You will also find several really interesting and alternative career pathways and great opportunities for further development in Global Regulatory Affairs. Many of the GRLs and Team Directors at this company are past placements of ours, showing how progression into global strategy or team leading is a strong possibility for those willing to work for it.
To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +1-855-505-1382, or send a full CV to CV@AdvTalent.com in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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