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Regulatory Affairs Manager (f/m)

Regulatory Affairs Manager (f/m) (office or home based - France)

Shared Work – Shared Vision: The way we do business, a promised standard that includes ongoing
support from a specialized team dedicated to meeting or exceeding our clients expectations.
Are you looking for a new challenge in a global and fast moving company? Then SynteractHCR offers you a
dynamic work environment as well as career development opportunities.
Your Tasks
  • Preparation and coordination of Clinical Trial Applications, including local submission procedures and local regulatory requirements
  • Compilation and review of all documents required for the submission to the Competent Authority, Ethics Committee and Institutional Review Boards
  • Submission of all relevant study documents to EC/IRB, CA, local authorities and institutions.
  • Preparation of core dossiers for other affiliates or subcontractors for submissions in other countries
  • Ensuring that clinical trials applications are conducted according to local and international requirements/procedures (ICH-GCP, applicable local law and guidelines, applicable SOPs)
  • Assistance with regulatory intelligence by monitoring the global regulatory environment and providing regulatory summaries
  • Collaboration with Clinical Operations and other internal departments if needed
  • Representing Regulatory Affairs in project teams and towards customers
Your Profile
  • Bachelor's degree in business, life sciences or a related field of study
  • 5+ years Regulatory Affairs experience in a CRO or the pharmaceutical industry
  • Strong understanding and knowledge of local requirements of Ethics Committees and Competent Authorities submission procedures according to international and national laws and guidelines
  • Experience in Marketing Authorization Applications, regulatory life-cycle management and Medical Device experience would be an asset
  • Proficiency in MS Office and regulatory databases
  • Effective verbal and writing skills (English)
What We Have to Offer
Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in their position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations.
To apply
Have we sparked your interest? Please apply online and let us know your earliest start date or notice period and your desired salary:
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Über SynteractHCR Deutschland GmbH

In early 2013, San Diego-based Synteract acquired Munich-based Harrison Clinical Research, forming SynteractHCR, a top tier international contract research organization. Through our expanded capabilities we support clinical trials globally, handling everything from emerging products through post-marketing. SynteractHCR is a full-service CRO with a successful track record of more than two...

Mehr über die SynteractHCR Deutschland GmbH

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