NCE’s: CMC RA Director and a CMC RA Associate Director ** Do you want a pure CMC RA Development role in a smaller, friendly R&D organization? * London, UK

Reference: ISC515B

Expiry Date: 22-11-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Watford
Hertfordshire
Великобритания

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Job Description

My client has regulatory hubs in both London and Amsterdam and are now hiring to support New Chemical Entities in Phases 2 and 3 and soon, pre-submission, for anti-infectives and new drugs in Rare Diseases.

What I like about this company and the roles is:

  • You want to work in a global environment supporting the EU Initial MA (MAA) in a company which is not short on resources or support! This is a pure development to first filing role!
  • You want to work in a smaller company which has Marketed Products (so it is stable) but is smaller, has less politics and more visibility with the Senior LT.
  • You want to be in a role where you can grow your team and develop your senior leadership skills for future development with a matrix organized team between 3 to 5 people.
  • You want to work on CMC M 2.x and 3 mostly on development, also, working with commercial and development teams, internal development experts and the CMC Regulatory teams.
  • You want to work in a small-sized pharmaceutical company with low politician noise and to have the opportunity to work mostly from home.
  • You will report directly to the Executive Director Regulatory CMC and have your own specific projects and accountabilities with success and visibility for your own achievements.
  • You will have expertise in preparing for and attending with the therapy RA Lead, HA meetings, managing CMC responses to HA queries as well as mitigation planning and problem-solving.
  • You want to be visible, have acknowledgement and visibility for you and your team’s successes.

What my client is looking for?

  • You will have CMC Regulatory experience for NCEs in Phases 2 or 3, so IMPDs, ideally you will have supported or led MAA M3 builds, or more than 1 or 2 major line extensions.
  • You will be passionate about people and know how to develop them in Regulatory CMC up the skills and confidence ladders.
  • You will know how to manage expectations of the stakeholders in US and EU, in team which is very diverse and multi-cultural.

What my client is giving in return?

An upper end basic salary for UK reserved for individuals with this type of expertise, plus high bonus level, car or car allowance with the opportunity to work from home most of the time.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Christian Atanasov on +44(0) 207 801 3382 or send a full CV to christian@advtalent.com and I would be happy to discuss the role further and give you more information. As we know the hiring manager, we will support you throughout the interview and on-boarding experience.

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