An excellent opportunity has arisen for an experienced regulatory professional to join my client, an established Regulatory consultancy, on an initial 12 month contract basis - the contract can be on a 6 or 12 month basis, full time or part time and fully remote based! The ideal person will have full life cycle experience, from CTAs through to registrations. As well as offering exposure to a broad range of projects, you will also be responsible for producing regulatory training materials for use on the other side of the business which offers courses for aspiring regulatory professionals.
Responsibilities will include:
As a Regulatory Affairs Manager, you will play a crucial role in guiding our clients through complex regulatory landscapes and helping to educate industry professionals. This role is ideal for a versatile and enthusiastic individual with comprehensive EU and UK regulatory experience, particularly in CMC, who are eager to learn, tackle new challenges, and make a significant impact on our company's growth and success.
Regulatory Strategy & Lifecycle Management
1. Strategic Guidance: Develop and implement robust EU and UK regulatory strategies for pharmaceutical and biotechnology products, from early-stage clinical development through to marketing authorisation and post-approval maintenance.
2. Full Lifecycle Support: Provide expert regulatory input for First-in-Human...