Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Em Regulatory Operations Specialist

Abbott
Abbott
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).

: