Senior/Principal Regulatory Affairs Specialist - CTA (Clinical Research Field) at Thermo Fisher Scientific

In this role you will be a pivotal team member with ideally with regulatory experience. You will provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision and marketing of these services.

You’ll work with the Regulatory Affairs management to perform the day to day operational aspects of the department such as: preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature. You will also act as primary point of contact for the sponsors of assigned projects.

The following skills are required to be successful in this position:

• Experience developing regulatory strategies globally
• Experience and knowledge of bid defence meetings
• Experience leading global regulatory projects
• Client facing experience

Education and experience:

• Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job
• Knowledge of the global clinical trials landscape
• Proven project management experience, and experience performing effectively in a client facing role

Knowledge, Skills and Abilities:

• Excellent command of the English language (written and oral) as well as local language where applicable
• Excellent attention to detail and quality as well as excellent editorial/proofreading skills
• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Excellent negotiation skills
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
• Excellent analytical, investigative and problem-solving skills
• Understanding of budgeting and forecasting