EM Regulatory Operations Specialist
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Job Location:
Monthly Salary:
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
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
- 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
- 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:
Bachelors 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/AIn 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)
Required Experience:
IC
Key Skills
- Financial Services
- Information Technology
- Cost Control
- Corporate Risk Management
- Law
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
