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    Manager - 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, Mumbai
    Travel: Low

    Job Overview

    We are looking for a Regulatory Affairs Specialist to manage all artworks and labeling components for Piramal Critical Care products globally. This role requires adherence to labeling processes to ensure compliance with innovator labeling, company standards, and GMP specifications. You will work in a cross-functional team environment to ensure that labeling documents and change requests are medically and scientifically accurate, compliant with regulatory standards, and aligned with company strategy.

    Reporting Structure

    • Reports to: Compliance Director, Regulatory Affairs

    Relevant Experience

    • Minimum 10 years of direct Regulatory Affairs experience with a focus on labeling and artwork.
    • At least 8 years of direct managerial experience.
    • Knowledge of global regulatory labeling requirements, including experience in the US, EU, and major Rest of World markets preferred.
    • Ability to multitask, prioritize effectively, and mentor junior staff in a fast-paced environment.
    • Strong leadership skills and the ability to engage with key stakeholders at a senior level.
    • Excellent written and verbal communication skills.
    • Experience with SharePoint and Harmony.

    Key Responsibilities

    • Manage global labeling details (labels, cartons, package inserts, patient package inserts) to ensure quality, compliance, evaluations, and approvals for regulatory submissions across regions (EU, LATAM, ROW, US).
    • Proofread all types of label copy at all developmental stages to ensure accuracy.
    • Coordinate with Graphics, Purchasing, Sales, Supply Chain, Manufacturing, and Regulatory Affairs teams through weekly calls to meet order timelines.
    • Prepare labeling-related documents (e.g., SmPC, PIL) for submission in the EU region.
    • Create SPL for US human and veterinary product submissions, drug listings, annual establishment registrations, and GDUFA self-identification.
    • Provide documentation support to manufacturing sites and resolve issues as they arise.
    • Ensure timely updates to all electronic databases used for product information storage, ensuring full compliance with GMP requirements.
    • Support the Regulatory Affairs department in audit readiness and during audits.
    • Assist the Compliance Director in investigations of non-conformances, including root cause analysis and implementation of corrective and preventative actions.
    • Create and revise SOPs and work instructions for labeling, including global harmonization.
    • Demonstrate commitment to attention to detail, teamwork, and personal accountability.

    Qualifications

    Essential:

    • BSc, B Pharm, or MSc degree in a scientific discipline.

    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 dedicated to delivering critical care solutions and expanding its footprint through new product additions.

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