Senior RA Specialist
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Senior Regulatory Affairs Specialist Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.
As part of our global team youll have the opportunity to serve as a senior contact in providing innovative solutions including regulatory expertise. As a Senior Regulatory Affairs Specialist youll interact with clients to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization. You will provide strategic expedient and efficient preparation of client deliverables that meet current local regional and ICH regulatory and technical requirements. Additionally you will act as a liaison with internal and external clients in the provision and marketing of these services.
What Youll Do:
Prepares and reviews regulatory submissions for China registration.
Provides regulatory strategy and/or technical advice to internal and external clients and acts as a liaison in executing strategies.
Leads the development and implementation of project-specific processes for sponsors.
Collaborates extensively with other departments regulatory consultants and regulatory authorities.
Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
Provides training and guidance to junior team members as appropriate.
Participates in project launch meetings review meetings and project team meetings.
Supports business development activities including project budgeting/forecasting.
Education and Experience Requirements:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 3 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:
Strong English language (written and oral) communication skills as well as local language where applicable
Solid attention to detail and quality as well as strong editorial/proofreading skills
Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
Solid 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
Solid 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
Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization licensing lifecycle management; good knowledge of ICH and other
global regulatory guidelines; basic understanding of a regulatory speciality areas such as preclinical clinical CMC publishing etc.
Solid understanding of medical terminology statistical concepts and guidelines
Strong analytical investigative and problem-solving skills
Working knowledge of budgeting and forecasting
Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.
Required Experience:
Senior IC
Key Skills
- Computer Hardware
- Mac Os
- Manufacturing & Controls
- Root cause Analysis
- Windows
- Customer Support
- Remote Access Software
- Operating Systems
- Encryption
- Remedy
- Chemistry
- Cerner
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
