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    Senior Executive - Labelling Regulatory Affairs

    Piramal Pharma
    4+ years
    Not Disclosed
    Mumbai
    10 Aug. 20, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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 Description: Regulatory Affairs Labeling Specialist

    Business Unit: Piramal Critical Care
    Department: Regulatory Affairs
    Location: Kurla, Mumbai
    Travel: Low

    Job Overview:

    The Regulatory Affairs Labeling Specialist is responsible for managing all artwork and labeling components for Piramal Critical Care products globally. The role ensures adherence to labeling processes, compliance with innovator labeling, and alignment with GMP standards and specifications. The specialist will participate in cross-functional teams to ensure labeling documents and associated change requests are medically and scientifically accurate, compliant with regulatory standards, and meet company needs and global regulations.

    Key Responsibilities:

    • Ensure quality and compliance in global labeling details, including labels, cartons, and package inserts.
    • Prepare labeling-related documents such as SmPC, PIL, and labeling texts for EU submissions.
    • Coordinate with stakeholders for timely submissions, approvals, and query resolution.
    • Proofread all types of label copy at all developmental stages to ensure accuracy.
    • Create SPL for US human and veterinary product submissions, including drug listing, annual establishment registration, and annual self-identification for GDUFA.
    • Monitor and process innovator-labeling updates for existing generic products, ensuring compliance with innovator updates through side-by-side comparison with RLDs.
    • Coordinate the development and updates of CCDS for PCC products and local labeling updates.
    • Contribute to the development and review of all labeling aspects included in promotional material.
    • Develop and maintain a central repository for all labeling components.

    Key Stakeholders:

    Internal:

    • Cross-Functional Teams: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Management

    External:

    • Country Distributors
    • Health Authorities (HA)
    • CMOs and External Partners

    Reporting Structure:

    Reports to the Regulatory Affairs Labeling Manager.

    Qualifications:

    • B.Pharm/M.Pharm
    • 4 years of relevant regulatory experience (Global experience including US, EU, and major Rest of World markets preferred).

    Competencies:

    • Strong interpersonal and organizational skills.
    • Knowledge of Health Authority labeling regulations and requirements.
    • Self-directed, motivated, organized, flexible, and accountable.
    • Excellent work ethic with a positive, can-do attitude.
    • Project management skills are a plus.

    About Piramal Critical Care:

    Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), is the third-largest producer of inhaled anesthetics globally and a leading player in hospital generics. PCC is committed to delivering critical care solutions worldwide, maintaining a strong presence across the USA, Europe, and over 100 countries. With state-of-the-art manufacturing facilities in the US and India, PCC's core strength lies in its highly qualified global workforce of over 400 employees across 16 countries. PCC continues to expand its global footprint through new product additions in the critical care space.

    Equal Employment Opportunity:

    Piramal Group is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based on race, ethnicity, religion, color, national origin, gender, sexual orientation, age, veteran status, disability, or any other legally protected characteristics. Employment decisions are based on merit, qualifications, performance, and achievements. We provide reasonable accommodation for qualified individuals with disabilities and those with needs related to religious observance or practice.

    About Piramal Group:

    For over three decades, Piramal Group has pursued growth through both organic and inorganic strategies, guided by its core values. Committed to inclusive growth and ethical practices, Piramal Group continues to expand while maintaining a focus on social responsibility.

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