Overview

Reference Number: JO-2211-504630
Senior Regulatory Consultant
Rate: Negotiable
Job Type: Permanent
Location: Central London / West End

Senior Regulatory Affairs Consultant

UK-based (Remote)

Competitive salary

An exciting opportunity to work as a Senior Regulatory Consultant for a drug development consultancy that supports development and lifecycle activities for a range of biotechnology and pharmaceutical companies. The business covers a broad range of innovative therapeutic areas such as Oncology, ATMP, Infectious diseases, and cell and gene therapy.

You will be responsible for the delivery of regulatory advice to clients, preparation of critical regulatory documentation, supporting multiple projects in development phases as well as managing lifecycle maintenance activities. 

Responsibilities

–       Provide strategic and tactical input in development, post-approval, and lifecycle management projects.

–       Knowledge of development activities such as PIP’s, ODD and scientific advice.

–       Input into technical documentation and process development including involvement in clinical trial applications (CTA), marketing authorization applications (MAA), and CMC.

–       Liaison with Regulatory Agencies, client companies and other stakeholders.

 Requirements

–       Bachelor’s degree in pharmacy, a life science or a biomedical discipline.

–       4 to 6 years of experience in regulatory affairs.

–       Previous experience working on drug development and managing the full lifecycle.

–       Ideally experience working with innovative products.

This is a great opportunity to join a rapidly growing drug development consultancy that is very well-funded and is looking to grow further in the next year. The role comes with a great benefits package as well as working within a very established team. The role has the flexibility to be fully remote across the UK, Ireland, and Malta.

If you are interested in this role or would like more details please email your CV to lucy.kirkaldy@cpl.com

Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.