PPD (Thermo Fisher) is seeking a Senior Regulatory Affairs Specialist to join their team remotely in the UK. The role involves providing regulatory expertise and strategic guidance for product development, while collaborating with clients and internal teams to ensure compliance with regulatory requirements
Job Summary
Serve as a senior contact in providing innovative solutions, including regulatory expertise.
Provide strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements.
Collaborate extensively with other departments, regulatory consultants, and regulatory authorities.
Matching Summary
Match Score: 85
PPD (Thermo Fisher) is seeking a Senior Regulatory Affairs Specialist to join their team remotely in the UK. The role involves providing regulatory expertise and strategic guidance for product development, while collaborating with clients and internal teams to ensure compliance with regulatory requirements.
Skills & Requirements
Must-have
regulatory intelligence and guidance
preparation of client deliverables
regulatory submissions
regulatory strategy and/or technical advice
collaboration with other departments
global/regional/national country requirements
Nice-to-have
client interaction
business development activities
training and guidance to junior team members
Key Requirements
Bachelor's degree or equivalent
5+ years of experience
Strong English language skills
Solid computer skills
Solid organizational, time management, and planning skills
Solid negotiation skills
Solid understanding of global regulatory guidelines