Regulatory Affairs Specialist

We are working with a global specialty pharmaceutical company that is seeking a Regulatory Affairs Specialist to be based in Slough on a contract basis. Reporting into the UK and Ireland Head of Regulatory Affairs, the job holder will provide subject matter expertise into the planning and execution of regulatory and product complaint activities for the company's UK and Ireland Operations.

This will include maintaining high quality marketing authorisations for company products as well as regulatory expertise into defining the optimum label through close collaboration with the company's group function, UK and Ireland Operations.

Job Responsibilities:

• Delivering Regulatory Affairs Leadership Support UK and Ireland Operations in the establishment and execution of robust regulatory plans for all relevant products and processes
• Arrange for submissions to be in line with the company's global regulatory strategy and local market needs
• Work with global regulatory colleagues in the preparation and submission of responses to regulatory authority questions
• Establish a constructive, responsive and assertive relationship with the regulatory authorities through a mixture of formal and informal communication channels.
• Maintaining compliance
• To ensure all the Regulatory Affairs activities are conducted within the framework and full compliance of national regulatory requirements, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), company's Standard Operating Procedures (SOPs) and Company policies, health and safety requirements, the Medicines Act and Industry Codes of Practice.
• Ensure all relevant company quality management system procedures /processes are adhered to, and develop new or revised written procedures (e.g. SOPs) as required Adhere to mechanisms for the orderly retention of regulatory correspondence to enable easy and secure document retrieval
• Participate when required in the review and approval of promotional materials, non-promotional materials, labelling and information items in line with the ABPI Code of Practice and UK statutory regulations.

Skills and Requirements:

• Postgraduate studies in either science or business
• A good understanding/appreciation of the UK commercial and healthcare environment for medicines
• Good level understanding of GxP requirements (primarily GDP and GMP)
• Good knowledge of current UK/EU regulatory framework for medicinal products
• Previous experience of managing a quality management system
• Previous experience of local complaints management
• Educated to graduate degree level in a scientific discipline
• At least 3 years' experience in a UK or EU regulatory role (relating to medicinal products)
• Demonstrable knowledge of current UK/EU regulatory framework for medicinal products
• Ability to plan, organise and coordinate multiple tasks effectively
• Good negotiation and influencing skills
• Strong attention to detail

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.