Gcp Compliance Manager (Gco)

8-9 years

Not Disclosed

Hyderabad India

10 Feb. 10, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Regulatory Affairs Specialist; Documentation
Location: India (Hyderabad, Office)
Job ID: REQ-10039385
Date Posted: Feb 05, 2025
Division: Development
Business Unit: Innovative Medicines
Employment Type: Full-Time, Regular
Shift Work: No

Job Purpose

The Regulatory Affairs Specialist in Documentation ensures compliance with regulatory requirements related to documentation, records retention, and information services. The role includes maintaining controlled documentation systems, ensuring adherence to regulatory guidelines, and supporting the development and submission of regulatory dossiers.

Key Responsibilities

Documentation Management & Compliance

Ensure controlled documentation systems and maintain records in line with regulatory requirements, including electronic records retention.
Implement procedures to classify and maintain technical and non-technical records.
Interpret and enforce documentation standards, policies, and operating procedures.
Ensure compliance with regulations for submission components, documentation formatting, and dossier assembly.

Regulatory Submission & Strategy

Manage medium to small-level global regulatory submission projects.
Provide technical input and regulatory intelligence to support the development, registration, and maintenance of global products.
Contribute to the implementation of global systems, tools, and processes that support development projects and marketed products.
Collaborate with internal teams and external contacts to drive regulatory processes.

Reporting & Analysis

Report technical complaints, adverse events, and special cases related to Novartis products within 24 hours.
Distribute marketing samples where applicable.
Analyze and evaluate data to extract pertinent information, preparing abstracts and executive summaries as needed.

Key Performance Indicators

Adherence to Novartis policies and guidelines.
Positive feedback from project stakeholders.
Successful management and execution of regulatory submission projects.

Qualifications

Experience & Skills

Work Experience:
- Cross-cultural experience with functional breadth.
- Collaboration across boundaries and effective operations management.
- Experience in project management and execution.
Skills:
- Clinical Study Reports.
- Data analysis and documentation management.
- Knowledge of life sciences and regulatory compliance.
- Operational excellence in managing regulatory processes.
Languages:
- Proficiency in English (both written and verbal communication).

Additional Information

Why Novartis: Novartis is committed to helping patients by fostering a collaborative work environment. We encourage smart, passionate individuals to join us in achieving breakthroughs that transform lives.
Commitment to Diversity & Inclusion: Novartis fosters an inclusive environment that reflects the diversity of the communities we serve.

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