Background:Our client is a full service, global CRO that manages all aspects of clinical development programmes for pharmaceutical and biotechnology companies. They are currently seeking a Regulatory Project Leader for Eastern Europe.
PRINCIPAL RESPONSIBILITIES include:
* Providing input and coordinating the input into marketing authorization and/or the study start up strategy for regions
* Coordinating Regulatory Specialists in the region working on submissions, applications for study start up and product approval
* Direct interface with sponsors
* Complete submission and application review
* Managing multiple regulatory projects globally
* Participating in clinical regulatory strategy development and implementation
* Managing assigned studies/projects in a timely manner in adherence with company SOPs, ICH, ISO, GCP and other regulations
* Participating in sales support, process improvement, training and supervision
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
* Background in medicine, science or other relevant discipline
* Thorough knowledge of regulatory and EC submission requirements in relevant countries
* Thorough knowledge of ICH, ISO, GCP and other relevant regulations for the conduct of clinical trials and marketing authorisations
* Thorough understanding of project management processes
* Experienced in developing regulatory strategies and putting together project plans
PERSONAL SKILLS & ATTRIBUTES:
* Excellent problem solving skills
* Strong people management and effective communication skills
* Good commercial awareness and customer focus
* Fluency in written and spoken English as well as the local country language
* IT literate
BENEFITS OF THE ROLE: This company offers outstanding opportunities at all levels and has emerged as a leading global CRO, composed of high performance teams, led by world class leaders who are dedicated to helping their customers bring products to market. They offer competitive salaries and comprehensive benefits.
Fforde is acting as a recruitment agency/business.
KEY WORDS: Regulatory Project Leader, Project Leader, Regulatory, CRO, Clinical Development, Drug Development, GCP, ICH, SOP, Medicine, Science, EC Submission, Clinical Studies, Clinical Trials, Project Management, Bulgaria, Czech Republic, Hungary, Poland, Romania, Russia, Serbia, Ukraine
