Regulatory Operations Specialist

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

     

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)

     

     

     

Experience Level

Mid Level