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Officer / Executive - Ra Eu

1-2 years
Not Disclosed
10 Dec. 31, 2024
Job Description
Job Type: Full Time Education: B. Pharma 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: Officer / Executive - RA EU

Date: December 25, 2024

Location: Maharashtra, India

Company: Lupin


Role Description:

The Officer / Executive - RA EU is responsible for the preparation of regulatory dossiers for various international markets, including Europe, Australia, New Zealand, and Canada. The role includes responding to regulatory queries, liaising with cross-functional teams, managing the life cycle of registered products, and ensuring adherence to regulatory guidelines and processes. This position plays a crucial role in maintaining regulatory compliance for Lupin's products in the EANC (Europe, Australia, New Zealand, and Canada) regions.


Key Responsibilities:

  1. Preparation of Dossiers:
    • Prepare regulatory dossiers for submission to regulatory agencies in Europe, Australia, New Zealand, and Canada (EANC).
  2. Regulatory Queries:
    • Respond to queries from regulatory agencies in the EANC regions, ensuring timely and accurate communication.
  3. Cross-functional Liaison:
    • Coordinate with R&D, manufacturing plants, clinical teams, and respective regional offices (EANC) to ensure smooth regulatory processes.
  4. Life Cycle Management:
    • Support the life cycle management of EANC registered products by ensuring timely approval of variations and regulatory updates.
  5. Data Maintenance:
    • Maintain departmental databases related to regulatory affairs, ensuring accuracy and up-to-date records.
  6. Regulatory Guidelines:
    • Regularly study and stay updated on the latest regulatory guidelines and electronic submission requirements to ensure compliance with evolving standards.

Relevant Work Experience:

  • 1 to 2 years of experience in regulatory affairs, preferably in the pharmaceutical industry.

Education Qualification:

  • B. Pharma (Bachelor of Pharmacy)

This role provides an excellent opportunity for candidates with a background in regulatory affairs to enhance their skills in preparing dossiers and responding to regulatory queries for key international markets. The ideal candidate will have a solid understanding of regulatory requirements and a strong ability to coordinate across teams to ensure compliance.