Expiry Date: 10-11-2021
Categories Biotech, Pharmacy, Regulatory Affairs
Job Type: Full Time
Manager or Senior Mngr Regulatory CMC Drug-Device Combinations ** RTP, North Carolina
About My Client
My client is a well-known and highly successful biotech with <> 10 high value drugs in market, and a significant size of T/O at approx. $15 Billion (the company generates 2-4 times as much value per employee than the average of the top 10 R&D Bio-tech companies). The organization are known for their science and I mean their ability to translate research and discovery into the successful development of new innovative medicines. They organize across multiple modalities, using successfully shared technology platforms, whether this is in manufacturing, or as it pertains to this role, for shared injectors and smart devices used across more than one drug in more than one treatment.
Note on Covid and location!
My client will consider hybrid working for experienced individuals or possibly remote working. The company will allow some home / office based on your skillset and initial capability. The site in North Carolina is a large campus, with both GMP and QA functioning in the same place. There are other regulatory teams based on-site. Relocation support is considered applicable for the right individual.
About The Role
These 2 new roles report to a line manager we know well, as we helped hire them, and the individual has implemented a ladder for you to ascend, whether you are a manager or a senior manager, you will be coached and mentored to take on more and more challenging projects, based on your starting points and long-term goals for your own career.
You will be working in matrix with therapy regulatory, regulatory CMC and quality, in support of the following:-
About Your Background
You will have between 2-5 years in Drug-Device Combination products from either a regulatory or development background (if you authored or co-authored regulatory submissions) or in a similar or more junior role. A minimum of 2 years’ experience with combination products; experience with drug delivery systems including PFS (pre-filled syringes) or AIs (auto-injectors) preferred.
You will receive a higher level basic salary and, depending upon grade, a bonus of upto 15% with both personal and company multipliers, and for the senior manager a stock plan.
The company will fund based on the individual some support for relocation if necessary, as well as provide funding for travelling into the office 2-3 times per quarter if you are remote.
If you wish to apply for this role, please contact me, Matt Greig, or Oli Dimitrov on 908-332-9157 for more information, or send a full CV to firstname.lastname@example.org. Alternatively, please press the red “Apply for position” button and follow the registration process.
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