EM Regulatory Operations Specialist

Job Description

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.

1. Relationships & Cross Functional team work

• Interacts with relevant stakeholders to ensure effective communication and continuous awareness
• Ensures continuous alignment and timely delivery

1. Coordination

• Demonstrates effective planning, follow up and co-ordination with relevant stakeholders
• Provides timely and high-quality support as per internal procedure

1. Compliance

• 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

1. Process Improvement

• 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
• Shows problem solving skills
• Seeks for performance continuous improvements

• Bachelors Degree in pharmacy, biology, chemistry, pharmacology, or related subject
• Minimum 2 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)