Senior Regulatory Affairs Associate - Cmc And Strategy

SciPro have exclusively partnered with an innovative pharmaceutical company who are driven by their purpose to reimagine how drugs can improve the quality of life of patients with rare disease. They are a fast growing, agile organization transforming the lives of patients and care givers through the use of cutting-edge pharmaceutical technologies to translate pioneering science to medicine products.

We are supporting them on their search for a Senior Regulatory Affairs Associate with a focus on CMC and Strategy. The successful candidate will join their Product Development team and will be responsible for pre- and post- approval CMC submissions, contributing to regulatory strategy for the development of new products. This is an exciting time to join a small team, with exposure to multiple projects and the ability to impact the lives of patients whilst building on your own professional experience.

Key responsibilities:

• Authoring CMC documentation
• Co-ordinate cross-functional stakeholders to ensure timely submissions in line with strategic goals and regulatory compliance standards
• Proactive input into technical and product development strategy

Key experience:

• Minimum 2 years of experience in authoring CMC submission documents
• Good formulation knowledge of medicinal products
• A demonstrable expertise for bespoke computer programmes would be highly desirable