Regulatory Specialist / Regulatory Affairs Specialist
Job Title: Regulatory Specialist
Location: Nantgarw, Cardiff (Flexible)
Position: Part Time, 12-month fixed term contract - maternity cover
Closing Date: 12:00 noon Wednesday, 7th August 2019
The company is a customised enzyme discovery, development and manufacturing company based in the UK, with a subsidiary in Illinois, USA. They work with their customers, many of which are the top blue chip food companies, to provide unique enzyme solutions that will help them solve process problems, valorise waste, facilitate a biochemical reaction or deliver competitive advantage through using a unique product.
They have an opportunity for a Regulatory Specialist to provide specialist support in regulatory affairs for 12 months’ maternity cover.
* To lead and coordinate the regulatory approval submissions for new enzymes
* To provide support for regulatory matters to ensure compliance with current and future enzyme regulations for the company’s sectors and primary geographical markets
* Prepare and deliver technical reports and information reports including new product regulatory submissions
* Effective and efficient communication with external stakeholders including consultants and regulatory bodies
* Carry out the responsibilities stated in the Managing Directors Health & Safety Policy detailed in paragraphs 9 and 10 of his management Directive
* Be conversant with and adopt the procedures stated in the Environmental Management System (EMS) Manual and its supporting documents
* On time product launches through timely submission of regulatory approvals for new enzymes as specified in project plans
* On time responses to customer regulatory enquiries as specified in Service Level Agreements
* Degree in Science, Regulatory Affairs or equivalent
* Knowledge of regulatory affairs in a food, pharma or biotechnology environment
* Analytical thinking
* Ability to learn
* Planning & Organisation
* Results driven
* Team Work
* 22.5 – 37.5 hrs - willing to be flexible
Please click on the APPLY button where you’ll be redirected to the company’s careers page.
Candidates with experience of; Regulatory Affairs, Regulatory Affairs Officer, Regulatory Affairs Associate, Regulatory Affairs Manager, Regulatory Affairs Administrator, Regulatory Affairs Manager, Regulatory Supervisor, Medical Equipment Quality Control, Compliance Manager, Compliance Officer, Compliance Associate may also be considered for this role.