Primary Job FunCTion
Support regulatory operational tasks within the Emerging Markets (EM) to ensure activities are completed consistently in a timely manner in accordance with Abbott policies, procedures and local regulations.
Overall scope consists of providing operational support to EM Regional and Local Regulatory Teams, primarily in :
1. Operational tasks in line with Abbott policies, procedures and local regulations
- Data management support into approved databases
- Data entry into approved databases
- Upload of data and documents into approved databases
- Compliance check of documents to ensure data accuracy
- Compilation support of data and documents into approved databases
- Publishing support
- Other administrative and operational tasks as per requirements.
2. Relationships & Cross Functional team work
Interacts 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) policy5. Process Improvement
Supports in streamlining and harmonizing relevant processesCreates SOPs, delivers training as applicableIdentifies opportunities and suggestions for continuous improvementsCORE COMPETENCIES
Technical competency
Demonstrates technical knowledge and good understanding of systems and toolsShows general understanding of regulatory requirementsIntegrity
Delivers high quality resultsMeets agreed deadlinesDisplays consistencyAdaptability
Shows flexibility and ability to work under pressureReacts quickly to solve problems and issues when they ariseManages priorities and align with manager in case of conflicts / prioritiesInitiative
Attempts to anticipate, mitigate issues and proactively flag risksShows problem solving skillsSeeks for performance continuous improvementsEducation / Qualifications / Experience
Bachelors Degree in pharmacy, biology, chemistry, pharmacology, or related subjectMinimum 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 Point)Skills Required
Pharmacy, Biology, Pharmacology, regulatory operations , Process Improvement, emerging markets