Website Tata Memorial Centre
POST NAME: EMERGING MARKET REGULATORY OPERATIONS SPECIALIST-1
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)
