Regulatory Affairs CMC Manager / Snr Manager, NCE’s - South East, UK

Reference: Oli10493A1R

Expiry Date: 26-12-2020

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Uxbridge
Greater London
United Kingdom

Apply for position

Job Description

 

We are recruiting for a Manager / Snr Manager Regulatory Affairs CMC to work on small molecule products in development for an established and successful Pharmaceutical company.

Our client is a leading, research driven Pharmaceutical Company with some exciting new products coming in Ph 2 and Ph 3 as well as a busy early development pipeline. This company has already grown to become a major R&D organization and are committed to increasing access to high-quality healthcare products around the world. This company is now expanding their Regulatory CMC team globally and is seeking to hire a Regulatory Affairs CMC Manager.

The location is easily commutable by train from London, Reading, High Wycombe, and Windsor and is easily accessible by car with company car parking available.

  • You will be working on a variety of projects. Based on your strengths and experience you would either be supporting a new MAA for a product in PIII or working on working on CTAs for products in development (authoring IMPDs, INDs, etc.).
  • 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.

Who’s right for the job?

  • It is essential to have at least 5 years of Regulatory Affairs CMC experience supporting and authoring M3 section for small molecules or biologics.
  • Experience in direct communication with the Health Authorities on CMC matters.
  • You would be a good communicator who is also eager to learn and develop.
  • You would have leadership and project management skills.
  • Fluent English is a must as this is the business language.

Benefits

This is a permanent opportunity and the salary is very competitive and includes a good bonus and an extensive company benefits package. There is also good flexibility to work 2 – 3 days a week from home. This role offers great projects to work on a real career development plan designed to give you all the experience you need to make the jump up to Regulatory Affairs Associate Director CMC.

Who are we?

ADV Talent is a niche recruitment agency hiring for major bio/pharmaceutical companies and healthcare organizations mainly in the field of Regulatory Affairs and Regulatory CMC. We want individuals to be self-actualized for their own hiring process. This brings out the individuals to embrace change and identify with their next career move as an opportunity to grow. By this, our applicants grow, and so do our clients.

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.

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.