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    Senior Executive Regulatory Affairs Labelling

    Piramal Pharma
    2+ years
    Not Disclosed
    Mumbai
    10 Oct. 29, 2024
    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 Opportunity: Regulatory Affairs Specialist

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

    Job Overview

    We are seeking a Regulatory Affairs Specialist to oversee all artwork and labeling components for Piramal Critical Care products worldwide. This role is crucial for ensuring compliance with innovator labeling, internal and external partner requirements, and GMP standards. You will work within a cross-functional team environment to ensure labeling documents are medically and scientifically accurate, compliant with regulatory standards, and aligned with company strategy and global regulations.

    Key Stakeholders

    • Internal: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Project Management, Senior Leadership Team
    • External: Country Distributors, Health Authorities (HA), Contract Manufacturing Organizations (CMOs), and external partners

    Reporting Structure

    • Reports to: Manager – Labelling

    Relevant Experience

    • Minimum 4 years of relevant regulatory experience, with global experience in the US, EU, and major Rest of World markets preferred.

    Key Responsibilities

    • Manage global labeling details (labels, cartons, package inserts, patient package inserts) to ensure quality, compliance, evaluations, maintenance, reviews, and approvals in collaboration with cross-functional teams for regulatory submissions.
    • Prepare labeling-related documents (e.g., SmPC, PIL) for submission in the EU region.
    • Coordinate with stakeholders for timely labeling-related submissions 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, drug listings, annual establishment registrations, and annual self-identification for GDUFA.
    • Monitor and process innovator-labeling updates for existing generic products, ensuring compliance with innovator updates.
    • Coordinate the development and updates of the Core Company Data Sheet (CCDS) for PCC products and manage 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 Competencies

    • Strong interpersonal and organizational skills for effective collaboration.
    • In-depth knowledge of Health Authority labeling regulations and requirements.
    • Self-directed, motivated, organized, flexible, and accountable.
    • Excellent work ethic with a positive attitude in a fast-paced environment.
    • Project management skills are a plus.

    Qualifications

    Essential:

    • Bachelor’s or Master’s degree in Pharmaceutical Sciences or a related field.

    About Us

    Piramal Group has pursued both organic and inorganic growth strategies for over three decades, driven by core values that emphasize inclusive growth and ethical practices.

    Equal Employment Opportunity
    Piramal Group is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based on race, ethnicity, religion, gender, sexual orientation, age, or any other legally protected characteristic.

    About the Team
    Piramal Critical Care (PCC) operates under Piramal Pharma Limited and is the third largest producer of inhaled anesthetics. With a global presence in over 100 countries, PCC is committed to delivering critical care solutions and expanding its footprint through new product additions.

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