Regulatory CMC? Do you want to work on late stage NCEs and file an initial MAA/NDA?

Reference: Oli10493JJ

Expiry Date: 12-11-2021

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time


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Job Description

Regulatory CMC? Do you want to work on late stage NCEs and file an initial MAA/NDA?

About the Role

My client is an R&D driven pharmaceutical company with several new products coming in Phase 2 and Phase 3, as well as a busy early development pipeline. This company is now expanding their Regulatory Affairs CMC team globally and are seeking to hire a Regulatory CMC professional to work on NCEs and initial MAAs.

In this role you will be working on a variety of projects based on your strengths and experience, but you will have the opportunity to gain more IMPD/IND authoring for products in late stage development in the EU and the US as well as Module 3 build for an initial Marketing Authorisation Applications. This company has planned several major submissions in the next few years. 

You will have both strategic and operational input for a variety of projects, potentially from early phase through to MAA as part of the Global Regulatory Affairs CMC development team. You will work with an experienced GRL who will help you develop and get to the next level in an organization where individuals are judged on their own merits.

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 1st 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 is based in 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.

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