Description
The RIO Execution Sr Associate is responsible for providing regulatory support to the International country and/or cluster Regulatory teams.
The role involves working across portfolio phases from initial registration applications, lifecycle management through to product withdrawal, and supporting numerous regulatory activities.
Key accountabilities include:
- Providing regulatory support to country Regulatory teams for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning.
- Authoring, delivery and/or coordination of local, submission-ready documents.
- Quality review/approval of the Dossier provided by Hub Submission/Dossier Managers.
The ideal candidate will have:
- A B.S./B.Scs. in Pharmacy, Life Sciences, Business or Information Technology.
- Advanced to Fluent English language required.
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
- Advanced Microsoft Office Suite skills.
The role requires self-initiation of problem-solving and the ability to navigate ambiguous situations.
The RIO Execution Sr Associate will interact with Country/Cluster teams, Submission Manager hubs, and other functions across RIO.
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