Description
Regulatory Affairs Manager - Regulatory Strategy - Clinical Research Organisation - Up to £60,000 basic - UKRegulatory Affairs Manager - Regulatory Strategy - Clinical Research Organisation - Up to £60,000 basic - UK
Up to £60,000 per annum plus benefits
7% pension (non contributory)
Healthcare
Dental
Private Medical
Life Assurance
Life Insurance
Sickness cover
You will be joining a leading provider of pharmaceutical support services as a Regulatory Affairs Manager. This company partners with life science companies to make medicinal products safer and more accessible for the consumer and through acquisitions; our client has grown from strength to strength. They handle both clinical and post approval work, however their speciality is clinical. Previous regulatory experience within a CRO is required and you will need a minimum of 5 years.
Key Skills/Requirements
- MS/MSc degree or the equivalent in a scientific discipline
- Circa 5 years Regulatory Affairs experience
- Regulatory experience in clinical trials, non-interventional studies and/or Registries, including the preparation and submission of CTAs, the applications for import licenses, and any reporting procedures, e.g, SAE reporting obligations and procedures.
- Very strong organization, planning and budget tracking abilities to handle potentially conflicting multiple portfolio projects.
- Strong leadership abilities to unite diverse groups to a common task and strategy.
- Excellent verbal and writing communication skills to collaborate with and discuss technical information and regulatory requirements with project teams and governmental agencies.
- Expertise with information management technology (e.g., archiving databases, document editing software, statistical manipulation of data).
- Demonstrated networking ability and negotiation skills to work within sponsor and government systems building expert networks and applying them to address business needs.
- Ability to work effectively with lengthy project review periods.
- Ability to work with all levels of management..
The company are still continuing to grow and encourage applicants with strong career ambitions to apply for the position. The role has the ability to progress you very quickly and give you the opportunity to build your own team.
If this is of interest to you and you would like to find out more information on this position or any other regulatory affairs positions, please contact Amanda Edwards on or please email a.edwards(a)realstaffing.com