Senior Manager Regulatory Affairs CMC – lead submissions for NBEs, UK, M4 Corridor

Reference: Oli104872

Expiry Date: 11-06-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Windsor
Windsor and Maidenhead
United Kingdom

Apply for position

Job Description

We are recruiting for a Snr Manager Regulatory Affairs CMC to lead projects in development for a leading biopharmaceutical company in the South East.

This is a permanent role for a Senior Manager Regulatory CMC, leading submissions for NBEs in the EU and the rest of the world.

Who is our client?

Our client is a fast-moving, international Biotechnology company, now expanding their Regulatory Affairs CMC team across the world. They are a global, 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 is people and produces successful drugs that make real difference to people around the world.

What will your duties be?

- Lead as assigned large molecule projects in development providing regional strategic and operational Regulatory CMC expertise.
- Write and review global and regional Regulatory CMC submission documents, IMPDs, MAAs etc.
- Manage CMC aspects of Health Authority questions.

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, supporting drugs in Ph2 and Ph3.
- The location is easily commutable by train from London and Reading and is easily accessible via car with company car parking on premises.
- Flexible working hours are available and the role comes with competitive salary, bonus and lucrative stock plan.

What do you need to bring to the table?

- It is essential to have at least 5 years of Regulatory Affairs CMC experience supporting and authoring dossiers for mAbs, vaccines, recombinant proteins, Cell & Gene Therapies or ATMP’s.
- Experience in successful authoring and compiling of IMPDs for biological products as well as MAA, Module 3 experience.
- Experience of direct communication with the Health Authorities.
- Demonstrated leadership, communication skills and emotional intelligence.

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.

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.

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.