EM Regulatory Operations Specialist
Abbott
**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** **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 suppo1t of data and documents into approved databases
+ Publishing support
+ Other administrative and operational tasks as per requirements
**Relationships** & **Cross Functional** **teamwork**
+ Interacts with relevant stakeholders to ensure effective communication and continuous Awareness
+ Ensures continuous alignment and timely delivery
**3.** **Coordination**
+ Demonstrates effective planning, follow up and co-ordination with relevant stakeholders
+ Provides timely and high-quality support as per internal procedure
**4.** **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
**Process lmprovement**
+ Supports in streamlining and harmonizing relevant processes
+ Creates SOPs, delivers training as applicable
+ Identifies opportunities and suggestions for continuous improvements
**Position** **Accountability/Scope:**
Technical competency
+ Demonstrates technical knowledge and good understanding of systems and tools
+ Shows general understanding of regulatory requirements Integrity
+ Delivers high quality results
+ Meets agreed deadlines
+ Displays consistency Adaptability
+ Shows flexibility and ability to work under pressure
+ Reacts quickly to solve problems and issues when they a1ise
+ Manages priorities and align with manager in case of conflicts/priorities Initiative
+ Attempts to anticipate, mitigate issues and proactively flag risks
+ Shows problem solving skills
+ Seeks for performance continuous improvements
**Minimum** **Education:**
Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related subject
**Minimum Experience/Training** **Required:**
+ 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
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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