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Team Member - Cdt

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 Description

Division:

IPD

Department:

IPD

Employment Type:

Permanent


Job Purpose

Responsible for compiling regulatory dossiers, managing deficiencies, evaluating products, and submitting tender documents to ensure compliance with regulatory requirements for various regulated and international markets within defined timelines.


Key Accountabilities

  1. Dossier Compilation:

    • Review and compile quality dossiers as per the latest regulatory guidelines and updates for regulated/international markets.
    • Ensure high-quality submissions to minimize deficiencies from health authorities.
  2. Deficiency Management:

    • Evaluate and prepare quality responses to deficiencies raised by health authorities or customers across all regions.
    • Deliver timely and compliant responses to meet health authority requirements.
  3. Product Evaluation and Tender Submission:

    • Assess and submit product evaluation and tender documents to regional teams.
    • Facilitate the conversion of DRFs (Drug Registration Files) and assist in product commercialization.
  4. Regulatory Updates and Training:

    • Stay updated on new regulatory guidelines and disseminate relevant information to teams.
    • Conduct ongoing training and interactions with regional teams to reduce deficiencies and improve compliance.

Educational Qualifications

  • Graduate or Postgraduate degree in Pharmacy or Life Sciences.

Relevant Experience

  • Minimum 5 years of experience in Regulatory Affairs or Quality Assurance.

Competencies and Skills

  1. Core Competencies:

    • Strong knowledge of regulatory affairs processes and guidelines for international markets.
    • Expertise in dossier compilation and deficiency management.
    • Familiarity with product evaluation and tender processes.
  2. Behavioral Competencies:

    • Collaborate to Succeed: Work effectively with cross-functional and regional teams.
    • Innovate to Excel: Introduce new approaches to improve compliance and efficiency.
    • Perform with Accountability: Take ownership of deliverables and ensure timely completion.
    • Lead with Empathy: Foster collaboration and support team members.
    • Act with Agility: Respond effectively to changes in regulatory requirements and priorities.
  3. Other Skills:

    • Excellent documentation and communication skills.
    • Proficiency in regulatory software and tools.
    • Ability to manage multiple tasks and meet deadlines.

Job Location

Vikhroli


Shift Hours

(To be determined based on operational requirements)


This role offers an exciting opportunity to contribute to Cipla's global regulatory initiatives. Join us to ensure the successful delivery of high-quality, compliant submissions that support product registration and commercialization worldwide!