Beschreibung
Regulatory Affairs Associate - CTAWe have a new opportunity for a regulatory affairs specialist to support clinical trials applications as well as some project in post marketing stage. This is a contract role 12 months - based in Switzerland
Major Accountabilities:
Responsible for implementing regulatory strategy and managing operational activities for assigned regions.
Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
Partners with regions to align on regulatory strategy in order to fulfil business objectives.
Implements RFP across assigned regions.
Works with RA GPT representative and/or GTAL to plan and facilitate presentations to regulatory boards on regulatory strategy
Coordinates and implements regulatory readiness with other line functions, Country Organizations and key opinion leaders.
Works with RA GPT representative and/or GTAL to interact with regulatory consultants/advisors for strategy input and challenge.
Represents RA on or leads sub-teams as required.
Contributes to development and implementation of plans to avoid/minimize clock stops during submission review.
Responsible for submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
Experience:
Experience with regulatory submission and approval processes
Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry.
Experience in HA negotiations.
prior experience in regulatory and drug/biologic development spanning activities in Phases I-IV
dossier submissions and approvals experience
Please send your CV to beata,
Michael Bailey International is acting as an Employment Business in relation to this vacancy.