Emerging Market Regulatory Operations Specialist-1

JOB DESCRIPTION:

Primary Job Function :

This is a newly created position to 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 - 4 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)

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:Regulatory OperationsDIVISION:EPD Established PharmaLOCATION:India > Mumbai : BKC BuildingADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Not specifiedMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Keyboard use (greater or equal to 50% of the workday)