Job Information
Abbott EM Regulatory Operations Specialist in Mumbai, India
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
Bachelor's 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)
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
Abbott
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