Job Description

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.

• You will have worked in regulatory CMC biologicals, for M2.x/3 and have re-authored expert reports into the dossier
• You might have 4-7 years in CMC Bio in RA, or have worked in analytical development, process development or bio manufacturing, and now want to consolidate and develop your regulatory CMC career in a company with both team leading and the GRL for CMC RA being available as a career path
• Alternatively, you might be an individual who has Bio RA CMC, but for early stage development, so IMPDs, Scientific Advice preparation for CMC RA, preparing CMC RA strategies, and working with development groups.

Why consider this role?

• You want to work in a company which is growing, has a successful track record in developing and registering molecules, and has a healthy financial outlook (shown by their share price)
• You want to work in a company which has not made redundancies in the last several years
• You want to work for the 1^st of our clients to react to Covid positively, and built out a digital hiring and digital working process (you will work from home until Covid abates, after, they offer 2 days at home, 3 in the office, but only when this is safe to do so)
• You will be working on a late stage Phase 3 program for a set of NMEs with all have decent Ph 2 data, and with the exception of 1 NME, they all have multiple indications
• This is a global team, even if you have only EU or Int’l CMC RA, you will gain US experience in due course
• The company have a track record of development Regulatory CMC Managers and Senior Managers to global strategy leading roles
• The company has 5-6 NMEs to file in the next 2-3 years, so even if clinical data does not pan out, you will have other NMEs to move to quickly!
• The company will consider archetypal Regs CMC people who have working in regulatory for 5-7 years, OR individuals who have less experience in Regulatory, but might have worked in a CMC or MSAT sub team, in analytical development or process development, and are regulatory aware
• You want to work under a matrix lead by a GRL who has a great deal of experience and knows how to grow / mentor individuals in a company which can offer variety and skills progression.

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!

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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