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EM Regulatory Operations Specialist

EM Regulatory Operations Specialist

ConfidentialMumbai
30+ days ago
Job description

Primary Job FunCTion

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

  • Bachelors Degree in pharmacy, biology, chemistry, pharmacology, or related subject
  • 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 Point)
  • Skills Required

    Pharmacy, Biology, Pharmacology, regulatory operations , Process Improvement, emerging markets

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