Manager

Sun Pharma

10-15 years

Not Disclosed

Baroda

10 Jan. 5, 2025

Job Description

Job Type: Full Time Education: MSc/M.Pharm 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

Manager - Lifecycle Management (R&D)
Date: January 1, 2025
Location: Tandalja - R&D, Sun Pharmaceutical Industries Ltd

Sun Pharmaceutical Industries Ltd, a global leader in the pharmaceutical industry, seeks a Manager for lifecycle management of development products within our R&D department. This role involves ensuring compliance with regulatory requirements and managing various aspects of the product development lifecycle, particularly in early-phase development.

Key Responsibilities:

Lifecycle Management and Knowledge Management

Oversee lifecycle management of development products in line with ICH guidelines.
Manage and document process changes during early-phase development.
Ensure regulatory compliance of clone development and cell banking documentation.

Regulatory Compliance and Documentation

Review and ensure compliance of product development documents such as process development reports, process descriptions, and process control strategies.
Ensure analytical developments such as method development, method qualification, and validation are aligned with the latest quality and regulatory requirements.
Develop, implement, and continually improve the Quality Management System (QMS) at R&D, ensuring alignment with corporate and site QA standards.

Data Verification and Documentation Practices

Verify laboratory data and ensure compliance with ALCOA++ principles (Attributable, Legible, Contemporaneous, Original, and Accurate).
Ensure good documentation practices (GDP) and accurate data reporting in line with industry standards.
Control the issuance of working copies and verification of raw data, ensuring proper archival of soft and hard copies of documents.

Regulatory Filing and CMC Review

Compile and review process and analytical documents for regulatory filing and CMC review.
Assist with dossier writing for regulatory agencies such as USFDA, EMA, and CDSCO.
Maintain audit readiness at all times, ensuring all documentation is prepared for regulatory agency, client, and business partner audits.

Audit and Inspection Readiness

Respond to audit queries from regulatory agencies, clients, and business partners.
Ensure the department is always audit-ready, maintaining high standards of quality and compliance.

Education and Experience:

MSc in Life Sciences or M. Pharm (Quality).
10-15 years of experience in quality assurance within the pharmaceutical industry.
Strong understanding of regulatory guidelines (RCGM, CDSCO, ICH, ISPE).
Exposure to product development, analytical development, CMC, and regulatory filing for recombinant products.
Experience with dossier writing for global markets such as USFDA, EMEA, Japan, and India.
Familiarity with biosimilar and biologics regulatory requirements, particularly for USFDA, EMEA, Japan, and India.
Prior experience in lifecycle management for global product development is advantageous.
Experience dealing with international inspections/audits from regulatory agencies and clients is preferred.
Excellent verbal and written communication skills in English are essential.

Key Competencies:

Regulatory Knowledge: In-depth understanding of international regulatory requirements, including for biosimilars and biologics.
Quality Management Systems: Expertise in developing and maintaining robust QMS within R&D environments.
Dossier Writing: Proven experience in preparing dossiers for regulatory submission.
Audit Readiness: Ability to maintain a state of audit readiness and handle queries from regulatory bodies and stakeholders.
Communication Skills: Strong verbal and written communication abilities to interact effectively with internal teams, regulatory agencies, and external partners.

Sun Pharmaceutical Industries Ltd offers a dynamic and challenging environment for professionals committed to advancing scientific innovation and regulatory compliance in the pharmaceutical industry. If you are a highly experienced quality assurance professional with a passion for R&D and regulatory affairs, this role provides an excellent opportunity to grow and make a significant impact on global product development.

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