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Group Leader - Api Tech Transfer

0-1 years
Not Disclosed
10 Nov. 28, 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

Division: IPD

Department: IPD

Employment Type: Permanent


Job Purpose

Support the IPD division by contributing to product development, lifecycle management, and ensuring regulatory compliance to meet business objectives and market requirements effectively.


Key Accountabilities

  1. Product Development Support:

    • Collaborate with cross-functional teams to facilitate efficient product development and ensure adherence to project timelines.
    • Ensure compliance with quality and regulatory standards during product development.
  2. Lifecycle Management:

    • Oversee post-approval product changes, renewals, and updates to maintain market presence.
    • Address product queries, regulatory challenges, and quality concerns to ensure business continuity.
  3. Regulatory Compliance:

    • Ensure documentation, processes, and systems align with global regulatory guidelines.
    • Support preparation and review of dossiers for market approvals and renewals.
  4. Process Improvement:

    • Identify opportunities for innovation and improvement in existing methods and workflows.
    • Stay updated on regulatory trends and implement best practices accordingly.
  5. Team Collaboration and Leadership:

    • Provide guidance and mentorship to team members.
    • Foster a collaborative environment to achieve departmental goals effectively.

Educational Qualification:

  • Graduate/Postgraduate in Pharmacy, Life Sciences, or Chemistry.

Relevant Work Experience:

  • Minimum 5 years of experience in pharmaceutical product development, regulatory affairs, or quality assurance.

Competencies and Skills:

  1. Core Competencies:

    • Collaborate to Succeed
    • Innovate to Excel
    • Perform with Accountability
    • Lead with Empathy
    • Act with Agility
  2. Technical Skills:

    • Strong domain knowledge of pharmaceutical product development and regulatory frameworks.
  3. Leadership and Management Skills:

    • Proficient in people management and team collaboration.

Job Location:

  • Bommasandra