Senior Regulatory Affairs Manager, Oncology in Uxbridge
Mary Bolt at CK Group is recruiting for a Senior Regulatory Affairs Manager - Oncology, to join a world leading pharmaceutical company at their site based in Uxbridge or Cambridge on a Permanent basis.
The Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. They are known as an innovator who are consistently pushing the boundaries of science and have a rapidly expanding pipeline.
The Location: Located less than an hour away from London by train, the role will be based in Cambridge or Stockley Park.
Cambridge is one of Britain's most beautiful cities, it still remains at the forefront of science and is one of Europe's most important biotechnology clusters.
Stockley Park was the UK's first and most successful business park. It has excellent transport links with the M4 and M25 motorways and Heathrow Airport few minutes away and a choice of railway and tube stations and extensive bus networks.
The main purpose of the role will be to:
- Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) and implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan) and direct the development of the regional product label by collaborating with the Labeling Working Group.
- Obtain and maintain Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs), communicate regulatory strategies as appropriate and estimate the likelihood of regulatory success based on proposed strategies.
Further responsibilities will include:
- Maintaining an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance and evaluate and communicate the impact of relevant regional regulations, guidances, current regulatory environment and competitor labeling.- Managing core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy, being responisble for these interactions and documenting and communicating details and outcomes.
- Advising EU regulatory leads on regulatory agency considerations in developing strategy and ensuring support of GRTs and managing resources within assigned area.
To succeed in this role, you will come from a background in:
- Educated to degree level or above in life science or a related field.
- Significant Regulatory Affairs experience including an understanding of the registration procedures in region for MA, post approval changes, extensions and renewals as well as national registrations.
- Excellent communication skills and experience of Health Authority interactions as well as cultural awareness to achieve results internationally.
The Benefits: A very competitive package is on offer.
For more information or to apply for this position, please contact Mary Bolt on 01438 768717 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL44371 in all correspondence.