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 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
5. Process Improvement
- Supports in streamlining and harmonizing relevant processes
- Creates SOPs, delivers training as applicable
- Identifies opportunities and suggestions for continuous improvements
CORE COMPETENCIES
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 arise
- 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
Education / Qualifications / Experience
- 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)
