Job Description

Description

:
  • Lead regulatory affairs for assigned 1/more franchise from clinical development up to life cycle maintenance 
  • Prepare regulatory strategies including risk mitigation plans for accelerated regulatory approvals of new products, clinical trials and ensure flawless implementation of regulatory strategies and drive SEC preparedness along with medical. 
  • In-depth knowledge of global/ local clinical trials and proactively efforts for India inclusion in global trials 
  • Ensure ~100% regulatory compliance as per internal and external expectations including post approval commitments, labelling, site transfers, biologicals.
  • In-depth knowledge of Indian regulations essential and regulatory expertise in innovative treament modalities is desirable
  • Ensure cross-functional collaboration locally (business, QA, medical, supply etc) and with International RA to ensure alignment of regulatory activities
  • Act as GRP lead and perform periodic reviews of RA function as per GRP Quality management systems.
  • Earlier initiatives of regulatory policy shaping and Health Authority advocacy efforts is necessary 
  • Ensure 100% regulatory compliance for assigned franchise 
  • Experience of earlier people management responsibility 

    • Core Accountabilities 

    The MC Regulatory Lead is responsible for: 

  • For assigned Franchise, accelerating approvals of innovative new products, additional indications and global clinical trials as per priorities and drive impactful SEC preparedness 
  • Act as lead for internal/ external audits if any for RA relevant areas, ensures deviations and CAPAs in place 
  • Ensuring the GRP areas under their responsibility are run in accordance with external regulations.
  • As GRP Lead, ensure that AZ's Good Regulatory Practices initiatives are implemented and comply with the planning established including: 
  • Ensure the training of the regulatory team for new procedures as well as updates on the current procedures. 
  • Active contribution in Industry association for regulatory policy advocacy efforts 
  • Cross functional collaboration and alignment across local teams as well as with International Regulatory affairs teams 
  • Ensures assessment of new regulatory guidance and impact assessment, implementation 
  • Regulatory support to Business Development projects 
  • Oversight of regulatory intelligence 
  • Reviews people development needs, closely monitors initiatives as needed 

    • Typical People Management Responsibility (direct/ indirect reports) – 3 to 4, approximate number of people managed in total (all levels)

    Education, Qualifications, Skills and Experience 

    Essential 

  • Pharmacy graduate 
  • People management experience 

    • Desirable 

  • Post-graduate qualification in Pharmacy 
  • Experience in regulatory affairs, drug development, clinical trials preferred 
  • Regulatory expertise in newer treatment modalities 

    • Key Relationships to reach solutions : (External to AZ)

    Industry Regulatory Bodies

    Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

    Date Posted

    23-Jan-2026

    Closing Date

    29-Jan-2026

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