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Officer / Executive - Ra Eu

1 to 2 years
Not Disclosed
10 Nov. 28, 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

This job description is for an Officer/Executive - RA EU position at Lupin, located in Maharashtra, India. The role is focused on regulatory affairs (RA) for advanced markets in Europe, Australia, New Zealand, and Canada (EANC). Candidates should have 1 to 2 years of relevant experience, with a B.Pharma qualification.

Key Responsibilities:

  1. Preparation of Dossiers:

    • Prepare regulatory dossiers for markets in Europe, Australia, New Zealand, and Canada (EANC) to meet local regulatory requirements.
  2. Response to Queries:

    • Address queries from regulatory agencies in the EANC regions, as well as from customers, ensuring compliance and smooth operations.
  3. Collaboration Across Teams:

    • Work closely with R&D, manufacturing plants, clinical teams, and the respective EANC offices/Business Development (BD) teams to align regulatory efforts.
  4. Life Cycle Management of Products:

    • Assist in managing the life cycle of EANC registered products, particularly by ensuring timely variation approvals.
  5. Database Management:

    • Maintain and manage departmental databases to ensure accurate and up-to-date regulatory information.
  6. Regulatory Guidelines Study:

    • Regularly study and stay updated on regulatory guidelines and electronic systems related to regulatory affairs.

Qualifications:

  • B.Pharma (Bachelor of Pharmacy)

Relevant Experience:

  • 1 to 2 years in regulatory affairs or a related field, ideally with exposure to international regulatory processes.

This position is ideal for someone starting or growing their career in regulatory affairs, with a focus on global markets. Strong organizational skills and the ability to manage cross-functional collaborations will be essential for success in this role.