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Opportunity to Work as Global CMC Regulatory Associate at Lilly-Apply before 30th September 2025

Lilly
Pharmacareer

Website Lilly

About Lilly

At Lilly, we unite caring with discovery to make life better for people everywhere. Headquartered in Indianapolis, Indiana, we are a global healthcare leader driven by innovation and compassion. Our teams worldwide work to discover and deliver life-changing medicines, enhance disease management, and contribute to communities through philanthropy and volunteerism. We believe in putting people first and are looking for passionate professionals who share our purpose.

Position: Global CMC Regulatory Associate

Key Responsibilities

Regulatory & Drug Development Expertise

  • Lead the CMC submission management process by applying knowledge of CMC regulatory requirements, ICH CTD, and evolving global standards.

  • Prepare high-quality CMC CTD content in alignment with approved manufacturing changes, technical reports, and regulatory procedures.

  • Collaborate with CMC RA Scientists to plan and deliver submission content supporting clinical studies and manufacturing process updates.

  • Support execution of global registration and lifecycle management submissions.

  • Review and respond to affiliate regulatory inquiries in consultation with CMC RA Scientists.

  • Interpret global regulatory guidance and incorporate regulatory precedents into submission processes.

  • Partner with Regional Submission Associates to align submission strategies, timelines, and requirements.

Leadership & Collaboration

  • Foster an environment that promotes open discussions and constructive challenges to achieve strong regulatory outcomes.

  • Share regulatory expertise across forums to ensure alignment with critical product registration and submission standards.

  • Communicate effectively within teams and across functions regarding lifecycle management processes.

  • Demonstrate problem-solving ability to address regulatory challenges across diverse geographies.

Candidate Profile

  • Education: Bachelor’s degree in Pharmacy, Chemistry, or a related scientific discipline.

  • Preferred Experience: Knowledge of pharmaceutical drug development and industry practices.

  • Additional Skills:

    • Understanding of agency submission procedures and evolving electronic submission standards.

    • Ability to manage regulatory operations in a compliance-driven environment.

    • Strong written, spoken, and presentation communication skills.

    • Negotiation, influence, and collaboration abilities.

    • High attention to detail and effective prioritization skills.

    • Proven ability to work in diverse teams and adapt to varied interpersonal styles.

Job Details

  • Qualification: Bachelor’s Degree in Scientific/Health Sciences discipline

  • Industry: Pharma / Healthcare / Clinical Research

  • Location: Bangalore, Karnataka

  • Job ID: R-92061

  • Application Deadline: 30th September 2025

Why Join Lilly?

  • Opportunity to contribute to a globally recognized healthcare leader.

  • Work in a collaborative environment focused on innovation, compliance, and patient impact.

  • Develop expertise in global regulatory processes while advancing your career in a purpose-driven organization.

To apply for this job please visit careers.lilly.com.