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Sr. Executive - Api

5+ years
Not Disclosed
10 Dec. 31, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Sr. Executive - API

Date: December 9, 2024
Location: Santacruz, Maharashtra, India
Company: Lupin


Role Description:

The Sr. Executive - API will be responsible for ensuring compliance with regulatory requirements related to the Drugs & Cosmetics Act, including managing applications for approvals and overseeing operational activities. This role also involves liaising with the West Zone CDSCO (Central Drugs Standard Control Organization) to ensure smooth regulatory processes for API products.


Key Responsibilities:

  1. Regulatory Knowledge:

    • Maintain a solid understanding of the Drugs & Cosmetics Act, particularly regarding the application process for approvals and the necessary operational activities.
  2. Liaisoning with CDSCO:

    • Act as the primary point of contact for liaising with the West Zone CDSCO, ensuring all required regulatory approvals for API products are managed efficiently.
  3. Operational Support:

    • Assist in managing the operational aspects of regulatory submissions and approvals, ensuring that all processes are carried out in line with regulatory guidelines.
  4. Documentation and Reporting:

    • Ensure accurate and timely submission of documents for regulatory approvals, as well as maintaining records for compliance.

Relevant Experience:

  • 5 years of experience in regulatory affairs or a related role, with a focus on API products and a strong understanding of the Drugs & Cosmetics Act.

Education Qualification:

  • Science Graduate (preferably with a focus in pharmaceutical or related sciences)

This role offers the opportunity to be part of a dynamic team, handling critical regulatory responsibilities for API products. The Sr. Executive will be essential in ensuring regulatory compliance and maintaining smooth relations with regulatory authorities, contributing to the company's success in the pharmaceutical market.