Job Description

Regulatory Affairs CMC Manager or Senior Manager, Berkshire, UK

This is a permanent role for a Manager / Senior Manager Regulatory Affairs CMC leading and submissions for NBEs in the EU and US the rest of the world. This is with a drug discovery company investing heavily in R&D as well as its people.

Who is our client?

Our client is a successful biotechnology company with a global reach. They develop innovative medicines for unmet medical needs and have an impressive pipeline of new molecules (NCEs and NBEs) coming up in development. They have some exciting new products coming in Phase II, Phase III and a number of products in early development. This company is committed to increasing access to high-quality healthcare products around the world.

The scope of the role:

This role will provide regulatory CMC expertise, leadership and oversite of projects in development in our client’s portfolio. You will have the opportunity here to work on a variety of indications, but also have the opportunity to follow through a molecule from Ph2/Ph3 to MAA/BLA in the EU and the US. You will have an input and support the implementation of regulatory CMC strategy as well as lead responses to the health authorities.

In this role you will:

• Lead as assigned and manage the Regulatory CMC aspects of Clinical Trial Applications for New Biological Entities.
• Provide regional strategic and operational Regulatory Affairs CMC expertise
• Write and review global and regional Regulatory CMC submission documents, IMPDs, INDs, new MAAs and NDAs etc.
• Lead and manage CMC aspects of Health Authority questions and negotiations.

What are the requirements?

• As a minimum you will have at least 5 - 8 years in the Pharmaceutical industry in a Regulatory Affairs CMC role. Don’t forget, we are recruiting for a Manager or a Snr Manager here, so we will accept applications with different lengths of experience and skill sets.
• You will have experience writing CMC documentation (IMPD, IND, PIP etc.) for development products – biologic or biosimilar.
• You will have experience authoring high quality Module 2.3 and Module 3 of MAAs or NDAs as part of a larger team and also some experience in lifecycle management, filing major variations, renewals, tech transfer etc.
• Experience preparing responses to CMC questions from Health Authorities is needed.

What is there for you?

In this company you will be given the opportunity to support or lead a project from early to late stage or submission right away. They like giving responsibility to Managers from the very beginning and promotions here don’t take long for the right person. Here you will work alongside experienced leaders who will help you learn, develop and get to the next level in your career.

The role comes with a competitive salary, company bonus, a comprehensive health and benefits plan including a high company pension contribution. It is possible to work 1-2 days from home and the location is easily accessible by car and commutable by public transport.

How does this sound? Feel free to inquire more information even if you are not sure that this is the right moment for you to have a career change. We look forward to hearing from you!

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.

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.

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. All applications are received in confidence! ADV Talent Partners will help you each and every step of the way through the hiring process!

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.

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