Description
The RIO Execution Hub Sr Associate is responsible for providing regulatory support to International country and/or cluster Regulatory teams.
The Execution Hub Sr Associates work across portfolio phases from initial registration applications, lifecycle management through to product withdrawal.
Key responsibilities include:
- Providing regulatory support 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
- Identification of regulatory requirements
- Support for local audit readiness activities, Dear Healthcare Professional Communication (DHPC) responses, and responses to medical info requests
Requirements:
- B.S./B.Scs. in Pharmacy, Life Sciences, Business, or Information Technology
- Advanced to Fluent English language required; multilingual skills desirable
- Proven technical aptitude and ability to quickly learn and use new software, regulations, and quality standards
- Advanced Microsoft Office Suite skills
- Familiarity with pharmaceutical organisational structures, systems, and culture is preferred
- Relevant experience within pharma, in Regulatory, quality, and/or compliance fields preferred
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