Emerging Market Regulatory Operations Specialist 8 views

Primary Job Function : This is a newly created position to 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 loc

Primary Job Function : This is a newly created position to 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: 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. Interacts with relevant stakeholders to ensure effective communication and continuous awareness Ensures continuous alignment and timely delivery Demonstrates effective planning, follow up and co-ordination with relevant stakeholders Provides timely and high-quality support as per internal procedure Ensures continuous compliance in alignment with Abbott procedures and regulations Maintains awareness of legislation and implement changes as relevant Ensure compliance with record retention (archiving) policy Supports in streamlining and harmonizing relevant processes Creates SOPs, delivers training as applicable Identifies opportunities and suggestions for continuous improvements CORE COMPETENCIES Demonstrates technical knowledge and good understanding of systems and tools Shows general understanding of regulatory requirements Delivers high quality results Meets agreed deadlines Displays consistency Shows flexibility and ability to work under pressure Reacts quickly to solve problems and issues when they arise Manages priorities and align with manager in case of conflicts/priorities Attempts to anticipate, mitigate issues and proactively flag risks u00A0 Shows problem solving skills Seeks for performance continuous improvements u00A0 Education/Qualifications/Experience Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, or related subject Minimum 2 – 4 years of relevant experience in regulatory operations Detailed oriented, communication, compliance and process Improvement skills. Computer Knowledge: Knowledge of the Office package (Ms Word, Ms Excel, Ms Power Point)

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