Expiry Date: 14-02-2021
Category Regulatory Affairs
Job Type: Full Time
About the Role
My client has late stage programs which require a significant amount of hiring in order to meet their pipeline commitments for Ph 3 programs. We are seeking an individual who can learn how to develop strategy in time, and wants to gain more M3 build experience, including authoring and re-authoring of sections for QoS and M3 for the first MAA/NDA/BLAs.
You will work in small tight team, to bring this core dossier build to pre submission, so working with sub CMC teams and manufacturing, as well as therapy regulatory, for timely submission.
Why consider this role?
Location (Post Covid)
During the next few months, my client will hire and on board you virtually, so you will be interviewed, inducted and on-boarded from home. After Covid, this role can be based in either Berkshire, M4 Corridor, UK or Brussels, Belgium. This role comes with relocation package to Belgium for anyone in Europe.
Package & Bens
My client is offering Manager or Senior Manager grading, for these positions, including a bonus, and incentives plan. The company is willing to consider individuals that want to work from home for 2 days a week post-Covid. You will receive continual training and mentoring, from individuals with 15-20 years each biologicals and Regulatory CMC.
To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.
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