EM Regulatory Operations Specialist

Job Description    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