Regulatory Affairs Lead- FSP

Work Schedule

Environmental Conditions

Job Description

Our Global Regulatory Affairs team is expanding! We are looking for a Regulatory Affairs Lead position to work for one of our key clients.

This a client dedicated role for a Regulatory Affairs Lead role: clinical expert role to support clinical trial new indications, including the early indications, early development and late development, and that can support later development. Global experience is a plus, EU CTR experience will be important.

The Reg Affairs Lead will act as the lead over several countries/projects in providing innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. They will provide strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. They will also act as liaison with internal and external clients in the provision and marketing of these services.

Essential Functions:

• Provides senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations, local and regional requirements.
• Acts as subject matter expert in providing regulatory strategy advice to internal and external clients on projects of moderate complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Participates in project management activities to support the provision of regulatory services, and acts as liaison with internal and external clients in the provision of marketing these services.
• Provides matrix/project leadership, training and guidance to junior team members to support understanding of regulations, impact on study, assessment of risk, etc., and to achieve a specific goal and/or project deliverables.
• May provide input on performance reviews to management.
• Ensures adherence to project budgets, time schedules, and scope of work.
• Ensures compliance with relevant organizational and regulatory SOPs and WPDs.
• Contributes to business development activities, including project budgeting/forecasting.

Qualifications:

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Excellent English language (written and oral) communication skills as well as local language where applicable
• Great attention to detail and quality as well as excellent editorial/proofreading skills

• Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Strong computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Strong 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
• Strong understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; good understanding of a regulatory speciality areas, clinical, in particular Clinical Trial Applications (CTA) including proven experience in submissions according to EU Clinical Trial Regulation.
• Experience in Global CTAs would be an advantage.
• Strong understanding of medical terminology, statistical concepts, and guidelines
• Excellent analytical, investigative and problem-solving skills
• Solid understanding of budgeting and forecasting
• Able to preform Line Managment responsibilities