Regulatory Affairs Specialist

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Our Regulatory Affairs global team within PPD® clinical research services deliver regulatory science services, providing regulatory knowledge which accelerates innovation and improves regulatory decision making – and helps our customers deliver life-changing therapies to patients faster.

Discover Impactful Work

Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.

A Day In The Life

• 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.
  
  

Keys To Success

Education

• Bachelors degree or equivalent and relevant formal academic / vocational qualification
  
  

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
  
  

Knowledge, Skills, 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
  
  

Working Environment

Requirements

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)

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