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Senior Executive Regulatory Affairs Labelling

2+ years
Not Disclosed
10 Nov. 19, 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 Title: Labeling Specialist - Regulatory Affairs

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


Job Overview

The Labeling Specialist oversees the creation, maintenance, and compliance of global labeling components, including labels, cartons, package inserts, and patient information leaflets. This role ensures adherence to regulatory standards, compliance with innovator labeling, and GMP specifications. The candidate will actively collaborate with internal and external stakeholders to manage labeling documents, streamline submission processes, and align with global regulatory requirements.


Key Stakeholders

Internal:

  • Cross-functional teams: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Pharmacovigilance, Planning, Project Management, and Senior Leadership

External:

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

Reporting Structure

Reports to: Manager – Labeling


Relevant Experience

  • Minimum 4 years of regulatory experience in labeling, preferably with global exposure (US, EU, and major Rest of World markets).

Key Roles & Responsibilities

  1. Global Labeling Management:

    • Develop, maintain, review, and approve labeling components (e.g., labels, cartons, and inserts) for regulatory submissions.
    • Ensure compliance with innovator-labeling updates, RLD evaluations, and regulatory requirements.
  2. Documentation:

    • Prepare labeling documents such as SmPCs, PILs, and related texts for submission in the EU.
    • Create SPL for US submissions, including drug listing, establishment registration, and GDUFA self-identification.
  3. Cross-functional Coordination:

    • Liaise with internal teams and external stakeholders to ensure timely submission and approval of labeling-related materials.
    • Collaborate with Medical Affairs for CCDS development and coordinate updates for local labeling.
  4. Quality Control:

    • Proofread and annotate all labeling materials to ensure accuracy and compliance at all development stages.
  5. Repository Management:

    • Develop and maintain a centralized repository for all labeling components.
  6. Regulatory Compliance:

    • Monitor regulatory changes, including HA labeling regulations, and adapt practices accordingly.
    • Contribute to the development and review of labeling aspects in promotional materials.

Key Competencies

  • Strong interpersonal and organizational skills.
  • In-depth knowledge of global Health Authority labeling regulations.
  • Self-motivated with a positive attitude to excel in a fast-paced environment.
  • Project management skills and attention to detail are essential.

Qualifications

Essential:

  • Bachelor’s or Master’s degree in Pharmaceutical Sciences or equivalent.

About Us

Piramal Critical Care (PCC), a division of Piramal Pharma Limited (PPL), is a global leader in hospital generics and the third-largest producer of inhaled anesthetics. With a presence in over 100 countries, PCC is committed to delivering critical care solutions for patients and healthcare providers worldwide.

PCC’s robust product portfolio includes inhalation anesthetics like Sevoflurane, Isoflurane, and Halothane, alongside intrathecal baclofen therapy for spasticity management. Supported by state-of-the-art facilities in the US and India, PCC adheres to rigorous regulatory standards, ensuring excellence in all aspects of its operations.

Driven by its values, PCC strives to create a sustainable impact through corporate social responsibility initiatives and environmental stewardship.


Equal Employment Opportunity

Piramal Group is proud to be an Equal Employment Opportunity employer, ensuring fairness in all personnel matters. Employment decisions are based on qualifications, performance, and achievements, with provisions for reasonable accommodations for individuals with disabilities and religious observances.


Join us at Piramal Critical Care and be a part of a dynamic team driving innovation and excellence in the critical care space.