Manager Ii - Health Authority Communications

7+ years

Not Disclosed

Bangalore

10 Jan. 5, 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

Manager II – Health Authority Communications
Date: December 25, 2024
Location: Tandalja - R&D
Company: Sun Pharmaceutical Industries Ltd
Reports To: Head of Health Authority Communication and Correspondence
Department: Global Quality
Functional Area: Global Quality
Location: Mumbai

Position Summary:

The Manager II – Health Authority Communications will play a crucial role in supporting global health authority communications and ensuring regulatory compliance across Sun Pharma. This individual will assist the Head of Health Authority Communication and Correspondence in coordinating regulatory responses, managing quality deliverables, and preparing materials for regulatory meetings. The role is designed for a quality professional with experience in various manufacturing environments (e.g., aseptic, solid oral dose) and Quality Management Systems (QMS), aiming to support health authority communication, remediation, and risk resolution.

Key Responsibilities:

Health Authority Correspondence Management:
- Review and prepare scientifically accurate, compliant responses to health authority queries and inspection observations.
- Collaborate with site teams to gather data and draft cohesive, concise responses.
- Track and manage all regulatory communication activities, ensuring accurate documentation in regulatory databases in a timely manner.
Quality Management System Analysis:
- Assess findings from inspections, audits, and Quality Management System reviews to identify areas for global risk mitigation.
- Support internal teams in developing corrective actions for identified issues.
Inspection Readiness:
- Provide support for regulatory audits, internal/external inspections, and other audits.
- Assist with mock inspections, reviewing documents for compliance with current regulations.
Compliance Tracking and Reporting:
- Monitor updates on regulatory requirements, especially related to aseptic environments and quality management.
- Perform gap assessments and provide recommendations for improvements.
Additional Assignments:
- Perform other duties as needed, contributing to the overall success of the health authority communication and regulatory compliance function.

Minimum Education/Experience Requirements:

Degree in a Science/Pharmacy related field.
7+ years of experience in quality assurance within the pharmaceutical industry, with experience in aseptic environments.
Microbiology experience is desirable.
In-depth knowledge of GxP, cGMP, Quality Systems, and other regulatory requirements.
Proficient in Quality Management Systems (QMS) and experience analyzing QMS data.
Significant experience in global health authority inspections and audits, with direct involvement in writing responses. Experience responding to FDA, MHRA, EMA, or WHO is preferred.

Required Success Attributes:

Strong understanding of Quality Management Systems (e.g., CAPAs, deviations).
Proficiency in regulatory tracking systems and Microsoft Office Suite.
Excellent attention to detail, technical writing, and collaboration with cross-functional teams.
Strong project management skills and the ability to manage multiple priorities in a fast-paced environment.
Consistent adherence to policies and maintenance of high ethical standards.
Ability to take initiative and identify improvement opportunities.

Secondary Success Attributes:

Commitment to continuous learning and staying updated with regulatory and industry best practices.
Ability to adapt quickly to new knowledge and embrace unfamiliar challenges.
Active participation in global harmonization activities.

Working Environment/Physical Requirements:

The position requires working in both office and manufacturing/packaging environments.
Moderate to loud noise levels are common in production rooms.
The incumbent must comply with gowning requirements for entry into controlled manufacturing areas and wear personal protective equipment as required.

Delegation of Responsibility:

Upward Delegation: Strategic corporate responsibilities to higher-level management.
Downward Delegation: Not applicable.

This job description provides an overview of the primary duties and responsibilities expected from the Manager II – Health Authority Communications position. It is not intended to be a comprehensive list of all tasks, and the incumbent may be required to perform additional duties as needed by management.

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Manager Ii - Health Authority Communications

Job Description

Position Summary:

Key Responsibilities:

Minimum Education/Experience Requirements:

Required Success Attributes:

Secondary Success Attributes:

Working Environment/Physical Requirements:

Delegation of Responsibility:

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