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Em Regulatory Operations Specialist

2+ 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

 


EM Regulatory Operations Specialist

Location: India - Mumbai (BKC Building)
Category: Regulatory Affairs

Primary Job Function:

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

Key Responsibilities:

1. Operational Tasks (Abbott Policies, Procedures & Local Regulations):

  • Data management support in approved databases.
  • Data entry and document uploads into approved databases.
  • Compliance checks to ensure data accuracy.
  • Compilation and publishing support for regulatory data and documents.
  • Other administrative and operational tasks as required.

2. Relationships & Cross-Functional Teamwork:

  • Interact with relevant stakeholders to ensure effective communication and awareness.
  • Ensure continuous alignment and timely delivery of regulatory activities.

3. Coordination:

  • Plan, follow up, and coordinate effectively with relevant stakeholders.
  • Provide timely and high-quality support per internal procedures.

4. Compliance:

  • Ensure continuous compliance in alignment with Abbott procedures and regulations.
  • Maintain awareness of legislation and implement changes as necessary.
  • Ensure compliance with record retention (archiving) policies.

5. Process Improvement:

  • Support in streamlining and harmonizing relevant processes.
  • Create SOPs and deliver training as applicable.
  • Identify opportunities and suggest continuous improvements.

Core Competencies:

  • Technical Competency: Strong understanding of regulatory systems, tools, and requirements.
  • Integrity: Delivers high-quality results, meets deadlines, and maintains consistency.
  • Adaptability: Works under pressure, quickly resolves issues, and manages priorities effectively.
  • Initiative: Proactively anticipates risks, identifies improvements, and demonstrates problem-solving skills.

Qualifications & Experience:

  • Education: Bachelor's Degree in Pharmacy, Biology, Chemistry, Pharmacology, or a related field.
  • Experience: Minimum 2 years of relevant experience in regulatory operations.
  • Skills: Detail-oriented with strong communication, compliance, and process improvement abilities.
  • Computer Knowledge: Proficiency in MS Office (Word, Excel, PowerPoint).

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