about 1 month ago
Job title: Regulatory Affairs Senior Manager - 12-Month FTC
A global pharmaceutical business in Hertfordshire is looking for a Senior manager to join on a 12-month FTC. The role is responsible for life cycle maintenance of key products and providing strategic support.
- To set objectives, deliver results and implement policies and operational targets that have a direct effect on the operational outcome.
- Contribute to the planning, execution, and assessment of product life cycle management activities.
- Contact with clients and external vendors to help troubleshoot routine client queries.
- Organises resources and processes across multiple teams to develop and deliver complete regulatory submissions within agreed timeframes.
- Substantial experience within Regulatory affairs and Pharmaceutical industry.
- Proven knowledge of UK regulations including clinical trial regulations.
- Experience in life cycle management for Centralised products, including Type I and Type 2 license variations, line extensions, and negotiating labelling with regulatory authorities.
- Oncology experience would be advantageous.
Salary and benefits:
A highly competitive salary and wider benefits scheme is on offer
To apply for this position or hear further details then please contact Freddie Hill via firstname.lastname@example.org