Title: Regulatory Affairs Manager II Career level: D
As a member of the Oncology Regulatory Science & Strategy Excellence team, the role holder will work with the Senior Director - Regulatory Business Development, supporting in/out Licensing and Partnership deals and execution of Transition Service Agreement (TSA) whilst establishing excellent collaborations and maintaining positive working relationships with third party partners (i.e., Licensing Partners, Outsourcing Partners). The –Post Deal Operations Manager II(PDOM) role sits in the Regulatory Business Development group and is of key importance in the delivery of AstraZeneca business development portfolio to ensure license transition in the most efficient and customer focused manner.
The PDOM will work closely with a broad cross-functional core transition team, comprised of functional representatives appropriate for the deal. As Post Deal Operations Manager for Regulatory Affairs (RA) you will support the RA Workstream in the core transition team. The PDOM will be accountable for regulatory transition activities to achieve relevant project milestones, as well as core business development operations delivery activities including but not limited to: Green Light Process, Preparation of documentation and Regulatory Activities.
The PDOM will collaborate with the equivalent external deal partner counterpart to agree the ways of working for the joint workstream team, engage in regular status issue and risk discussions, to ensure smooth transitions.
Working with designated stakeholders to ensure various cross functional activities are managed with appropriate timing to align with regulatory transitions, including but not limited to documentation review as per Mergers and Acquisition timelines, Patient Safety agreements are in place, supply has appropriate stock builds planned and artwork changes are considered.
Responsibilities:
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