EM Regulatory Operations Specialist
Abbott Laboratories
Core Job Responsibilities:
Overall scope consists of providing operational support to EM Regional and Local Regulatory Teams, primarily in:
Operational tasks in line with Abbott policies, procedures and local regulationsData management support into approved databasesData entry into approved databasesUpload of data and documents into approved databasesCompliance check of documents to ensure data accuracyCompilation suppo1t of data and documents into approved databasesPublishing supportOther administrative and operational tasks as per requirementsRelationships & Cross Functional teamworkInteracts with relevant stakeholders to ensure effective communication and continuous AwarenessEnsures continuous alignment and timely delivery3. Coordination
Demonstrates effective planning, follow up and co-ordination with relevant stakeholdersProvides timely and high-quality support as per internal procedure4. Compliance
Ensures continuous compliance in alignment with Abbott procedures and regulationsMaintains awareness of legislation and implement changes as relevantEnsure compliance with record retention (archiving) policyProcess lmprovementSupports in streamlining and harmonizing relevant processesCreates SOPs, delivers training as applicableIdentifies opportunities and suggestions for continuous improvementsPosition Accountability/Scope:
Technical competency
Demonstrates technical knowledge and good understanding of systems and toolsShows general understanding of regulatory requirements IntegrityDelivers high quality resultsMeets agreed deadlinesDisplays consistency AdaptabilityShows flexibility and ability to work under pressureReacts quickly to solve problems and issues when they a1iseManages priorities and align with manager in case of conflicts/priorities InitiativeAttempts to anticipate, mitigate issues and proactively flag risksShows problem solving skillsSeeks for performance continuous improvementsMinimum Education:
Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related subject
Minimum Experience/Training Required:
Minimum 2 years of relevant experience in regulatory operationsDetailed oriented, communication, compliance and process Improvement skills.Computer Knowledge: .Knowledge of the Office package (Ms Word, Ms Excel, Ms Power
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