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

• 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
  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

The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

EPD Established Pharma:

LOCATION:

• India > Mumbai : Mumbai Development Center
• EPD

ADDITIONAL LOCATIONS: ###WORK SHIFT:
Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)