Regulatory Affairs Executive

G&L Scientific is a leading consultancy specializing in Regulatory Affairs and Quality Assurance. Our mission is to provide expert guidance that empowers our clients to navigate complex regulatory environments effectively.

We are seeking a dedicated Regulatory Affairs Executive to join our team in Belfast. In this role, you will play a crucial part in ensuring compliance with regulatory standards, contributing significantly to our mission of delivering high-quality consultancy services. We are looking for someone who is

enthusiastic and willing to develop the skills and knowledge required of a Regulatory Affairs professional in areas such as the drug development process, regulatory affairs, submissions management, publishing and/or other regulatory operations activity and requires a quality approach to documentation and an eye for detail.

Responsibilities

• Keeping up to date with national and international regulatory legislation, guidelines, and customer practices
• Sharing of knowledge such as supporting the generation of training materials and regulatory intelligence
• Researching and authoring thought leadership content, to help build knowledge and understanding in a regulatory discipline.
• Support on high output regulatory project(s), which may involve preparation of high quality CMC regulatory documents using varied information sources and Regulatory Information Management (RIM) ensuring compliance in customers data.[
• Liaising closely with other stakeholders to ensure accuracy and completion of tasks to strict timelines.
• Working to agreed deadlines and maintaining records to reflect project status
• Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. Proactively pursuing process improvement and sharing of best practice

Required Skills

• Science related degree e.g Biological Sciences, Biomedical Science.[RO5]
• Desirable: Previous experience in a Regulatory Affairs role.[RO6]
• Strong written and oral communication and networking skills
• Demonstrate ability to focus and work with attention to detail
• Demonstrate ability to retain critical information
• Demonstrate team working and effective time management skills
• Be a dynamic and highly motivated individual
• Establish strong relationships and liaise effectively with all applicable stakeholders.
• Be proficient in the use of IT packages such as Word and excel.
• Demonstrate problem solving skills

If you are passionate about regulatory affairs and want to make a difference in the industry, we invite you to apply and join our dynamic team!