Associate Director Regulatory Affairs CMC - South East, UK

Reference: Oli10564

Expiry Date: 26-12-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Uxbridge
Greater London
United Kingdom

Apply for position

Job Description

Associate Director Regulatory Affairs CMC - South East, UK

We are recruiting for an Associate Director (GRL) CMC to lead projects in development for a global biopharmaceutical company in the South East of England (M4 Corridor).

This is a permanent role for a Regulatory Affairs CMC professional, setting the Regulatory CMC strategy and leading submissions for NCEs globally.

Who is our client?

Our client is a major biotechnology company with impressive levels of growth and achievement. This organization is now expanding their Regulatory Affairs CMC team across the world. They are highly profitable, R&D driven business that has over the years pushed the boundaries of what is possible in order to transform patients’ lives. This company invests heavily in cutting-edge scientific research, it supports and develops its people and produces successful drugs that make real difference to people around the world.

What will your duties be?

  • Lead NCEs in development providing strategic and operational Regulatory CMC expertise. Initially, the role will focus on taking the lead for strategic activities in the EU and the US and then major international regions and territories for a combination product in Ph 3, with the global MAA/NDA planned for 2022-23.
  • Review and approval of global Regulatory CMC submission documents, IMPDs, MAAs etc.
  • Lead and manage the CMC aspects of Health Authority questions.
  • Lead and manage cross-functional teams. Gradually, the role will also develop into a leading/people management role.

What is there for you?

  • Become part of a highly successful biotechnology company that nurtures a team culture of mutual respect and support.
  • Work on variety of projects in development (post-approval is managed by a separate team) moving on to oligonucleotides and gaining biologicals experience if you wanted to. This will be a highly visible role as you will be the small molecule expert in the company. 
  • The location is easily commutable by train from London and Reading and is easily accessible via car from anywhere in Berkshire, North Surrey and South Bucks with company car parking on premises.
  • Flexible working hours are available post Covid-19 and the role comes with very competitive salary, bonus car allowance and a stock plan.

What do you need to bring to the table?

  • It is essential to have at least 7 years of Regulatory Affairs CMC experience supporting and authoring dossiers for small molecules in development (particularly late stage), authoring and compiling of IMPDs as well as Module 3 for initial MAA/NDAs.
  • Regulatory CMC strategy experience is needed as well as experience of direct communication and negotiation with Health Authorities.

Demonstrated leadership, ability to work independently (this company will empower you) and communication skills are needed.

To Apply!

To apply for this role, please contact Theo Moore on +44 207 801 3384 or Oli Dimitrov on +44 207 801 3388. Alternatively please send a full CV to Theo@advtalent.com or follow the registration process on the site and we will reply by return.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380 for UK and 855.505.1382 for USA.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.