Regulatory Affairs Specialist

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Essential Functions and Other Job Information:

• Supports the preparation of documentation and submissions under guidance.
• Coordinates and manages client deliverables supporting regulatory compliance.
• Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting.
• Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.
• Assists in business development and pricing of projects for the department. Evaluates client needs in relationship to overall project timelines, quality and delivery.
• Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed.

Qualifications - External

Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous exp

Knowledge, Skills and Abilities:

Good English language (written and oral) communication skills as well as local language where applicable

Good attention to detail and quality as well as editorial/proofreading skills

Good interpersonal skills to work effectively in a team environment

Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies

Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects

Good negotiation skills

Capable of working independently with direction and exercising independent judgment

Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables

Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management

Basic understanding of medical terminology, statistical concepts, and guidelines

Good analytical, investigative and problem-solving skills

Capable of interpreting data