Opportunity to work as Associate Manager– CMC Regulatory Writing at Elanco-Apply before 30th June 2025

About Elanco Animal Health

Elanco Animal Health Incorporated is a global leader in the development of pharmaceutical products and vaccines for pets and livestock. Formerly a subsidiary of Eli Lilly and Company, Elanco has grown into the world’s third-largest animal health company, driven by innovation, science, and a commitment to improving animal well-being.

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Position Overview

We are hiring an Associate Manager – CMC Regulatory Writing to support global Chemistry, Manufacturing, and Controls (CMC) regulatory activities. This role involves creating and managing regulatory strategies and documentation for the maintenance and expansion of global registrations/approvals for animal health products.

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Key Responsibilities

Regulatory Strategy & Documentation

• Develop and implement global CMC regulatory strategies for new and marketed animal health products.

• Author high-quality CMC documentation in compliance with FDA/CVM, EMA, and global guidelines.

• Ensure timely and accurate submission of CMC documents, variations, renewals, and annual reports.

Cross-functional Collaboration

• Collaborate with internal teams (R&D, Manufacturing, Quality) and global regulatory partners.

• Lead and coordinate cross-functional submission activities ensuring alignment with global strategies.

• Communicate key regulatory strategies and submission milestones effectively to stakeholders.

Compliance & Knowledge Management

• Maintain up-to-date knowledge of global CMC regulatory requirements and technical trends.

• Provide regulatory training to internal teams as needed.

• Ensure documentation accuracy, completeness, and compliance with regulatory standards.

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Candidate Profile

Qualifications

• Master’s or Bachelor’s degree in Science, Pharmacy (B.Pharm/M.Pharm), or Veterinary Sciences.

Experience

• Minimum 5 years in Global Regulatory Affairs, specifically in CMC life cycle management.

• Proven experience with regulatory submissions in the US (FDA/CVM) and/or EU (EMA).

• Familiarity with cGMP requirements and regulatory information management tools.

Key Competencies

• Excellent written and verbal communication.

• Strong decision-making skills in ambiguous situations.

• High attention to detail and organizational skills.

• Proactive, self-driven, and timeline-oriented.

• Ability to manage multiple projects in various phases simultaneously.

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Why Join Elanco?

• Be part of a globally recognized organization focused on innovation and animal well-being.

• Work in a collaborative, science-led environment.

• Opportunity to lead regulatory activities impacting global health outcomes.

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How to Apply

Interested candidates may submit their application online through Elanco’s careers portal referencing Job ID: R0022416 by 30th June 2025.

Explore your potential with Elanco – where your work makes a difference.