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Reg Affairs Specialist; Documentation

3+ years
Not Disclosed
10 Feb. 7, 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

Here’s the rewritten job description along with a unique slug:


Regulatory Affairs Specialist – Documentation

Job ID: REQ-10039385 | Date: Feb 05, 2025 | Location: India

Summary

As a Regulatory Affairs Specialist – Documentation, you will be responsible for maintaining a controlled documentation system, ensuring compliance with regulatory requirements, and managing record retention processes, including electronic records. You will play a key role in enforcing documentation standards, maintaining the documentation change system, and ensuring adherence to regulatory guidelines. Additionally, you may assist in identifying submission components, coordinating regulatory dossier assembly, analyzing data, and summarizing critical information. Your expertise will support both technical and non-technical documentation, contributing to compliance and regulatory strategy execution.

About the Role

Key Responsibilities:
  • Manage global regulatory submission projects of small to medium scope.
  • Provide regulatory submission expertise and contribute to technical regulatory strategy and intelligence.
  • Support the implementation of global systems, tools, and processes for product development and compliance.
  • Collaborate with internal teams and external stakeholders to ensure regulatory compliance.
  • Work on moderately complex problems requiring analysis of multiple factors.
  • Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours.
  • Oversee the distribution of marketing samples (if applicable).
Key Performance Indicators:
  • Adherence to Novartis policies and guidelines.
  • Effective project execution and stakeholder feedback.

Minimum Requirements

Work Experience & Skills:
  • Experience in regulatory documentation and compliance.
  • Ability to collaborate across cultures and functions.
  • Strong project management and operational execution skills.
  • Proficiency in clinical study reports, data analysis, documentation management, and regulatory compliance.
  • Knowledge of life sciences and operational excellence.
Languages:
  • Proficiency in English.

Why Join Novartis?

At Novartis, we go beyond innovative science—we build a passionate, collaborative community to transform patients’ lives. Ready to be part of a team that makes a difference? Learn more: Novartis Careers

Join Our Talent Network

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Benefits & Rewards

Discover how we support your personal and professional growth: Novartis Benefits & Rewards

Division: Development
Business Unit: Innovative Medicines
Location: Hyderabad, India
Company: Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full-time | Employment Type: Regular | Shift Work: No

Accessibility & Accommodation

Novartis is committed to fostering an inclusive environment and providing reasonable accommodations for individuals with disabilities. If you require assistance during the recruitment process, contact diversityandincl.india@novartis.com with the job requisition number.

At Novartis, we strive to build diverse teams that reflect the patients and communities we serve.