Em Regulatory Operations Specialist

2+ years

Not Disclosed

Mumbai

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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Em Regulatory Operations Specialist

Job Description

Primary Job Function:

Key Responsibilities:

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

2. Relationships & Cross-Functional Teamwork:

3. Coordination:

4. Compliance:

5. Process Improvement:

Core Competencies:

Qualifications & Experience:

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