Regulatory Officer Jobs east midlands
Regulatory Officer
My client are looking for a contract regulatory officer to Support the Drug Delivery Systems Business in the development and commercialisation of a range of pharmaceutical products for customers on a global basis.
The role is for intially a contract of 3 months with the chance of being extended, based on performance and will include membership of development and commercialisation teams providing regulatory advice on new product development and maintenance issues. Co-ordination of regulatory documentation including CTD and CEP documents to support new submissions and product changes. Responsibility for estimation and monitoring of regulatory resource requirements.
The successful candidate will work directly with Product Development and Product Assurance Technical Teams and customers to ensure generation of approvable Global regulatory data packages to new submissions and support change.
Key Skills, Qualifications, Attributes and Capabilities
Candidates will need proven project planning skills, strong written and verbal communication skills.
Highly developed interpersonal and team skills with experience of dealing with external customers.
The candidate will need to be strategic in thinking and someone who can deliver regulatory solutions and easily adaptive to change and new circumstances.
They will need to possess the ability to handle multiple and complex tasks and be comfortable getting involved in detailed regulatory work as well as understand the bigger picture.
They will also need to be capable of understanding the business needs and priorities and translating these into appropriate regulatory actions.
My client has expressed that applicants have regulatory experience, preferably with Marketed products on a global basis.
Academic Qualifications
Bachelors degree in Science.
Diploma in Regulatory Affairs would be advantageous.