Beschreibung
A new opportunity has been opened for experienced Regulatory Affairs Manager to support busy team with submission for products in the development stage.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 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.
Works with RA GPT representative and/or GTAL to interact with regulatory consultants/advisors for global strategic input and challenge.
Develops and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders, and ensures integration with global regulatory readiness with RA GPT representative and/or GTAL.
Represents RA on or leads sub-teams as required.
Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
Reviews and submits Risk Management Plans.
9May lead negotiations for regional approvals independently or with RA GPT representative and/or GTAL.
Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the RA GPT representative and/or GTAL.
Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with RA GPT representative and/or GTAL, consistent with development data and commercial objectives of the TPP.
Responsible for finalization and on time submission of annual reports and renewals across assigned regions.
Reviews promotional and non-promotional materials and press releases as required and work with RA GPT representative and/or GTAL to ensure messages are consistent with policies and guidelines.
Requirements:
BS or MS with requisite experience and demonstrated capability.
Languages: Fluency in English as a business language.
Strong knowledge of regulatory submission and approval processes in 1 or more major regions.
Experience leading regulatory submissions and approvals in at least 1 major region.
Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry
Experience in HA negotiations. regulatory and drug/biologic development spanning activities in Phases I-IV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.