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Emerging Market Regulatory Operations Specialist-1

2-4 years
Not Disclosed
10 March 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 


Emerging Market Regulatory Operations Specialist-1

Location: India - Mumbai
Category: Regulatory Affairs

Primary Job Function:

This newly created position supports regulatory operational tasks within Emerging Markets (EM) to ensure activities are completed consistently and in a timely manner, in accordance with Abbott policies, procedures, and local regulations.

Responsibilities:

1. Operational Tasks

  • Data management support in approved databases
  • Data entry and document uploads into approved databases
  • Compliance check of documents for data accuracy
  • Compilation and publishing support
  • Other administrative and operational tasks as required

2. Relationships & Cross-Functional Teamwork

  • Interact with relevant stakeholders for effective communication
  • Ensure continuous alignment and timely delivery of tasks

3. Coordination

  • Plan, follow up, and coordinate with stakeholders
  • Provide timely and high-quality support in line with internal procedures

4. Compliance

  • Ensure continuous compliance with Abbott procedures and regulations
  • Stay updated on legislation and implement changes as needed
  • Maintain compliance with record retention (archiving) policies

5. Process Improvement

  • Support process streamlining and harmonization
  • Create SOPs and deliver training as required
  • Identify opportunities for continuous improvements

Core Competencies:

Technical Competency

  • Strong technical knowledge of systems and tools
  • General understanding of regulatory requirements

Integrity

  • Deliver high-quality results within deadlines
  • Maintain consistency and compliance

Adaptability

  • Work flexibly under pressure and solve problems efficiently
  • Manage priorities and align with the manager when needed

Initiative

  • Proactively identify and mitigate risks
  • Demonstrate problem-solving skills and continuous improvement mindset

Education, Qualifications & Experience:

  • Education: Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, or a related field
  • Experience: 2 - 4 years of relevant experience in regulatory operations
  • Skills: Attention to detail, communication, compliance, and process improvement skills
  • Computer Knowledge: Proficiency in Microsoft Office (Word, Excel, PowerPoint)