Manager – CMC Regulatory
Company: Elanco
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Department: Global Regulatory Affairs – CMC
Experience: 8+ Years
About the Role
Elanco is seeking a Manager – CMC Regulatory to support global Chemistry, Manufacturing & Controls (CMC) regulatory activities for approved and marketed animal health products. The role involves developing regulatory strategies, managing product lifecycle activities, preparing global submissions, and ensuring compliance with international regulatory requirements.
The successful candidate will work closely with Manufacturing, Quality, R&D, and Regulatory teams to support post-approval CMC changes, renewals, variations, supplements, and annual reporting activities across global markets.
Key Responsibilities
CMC Regulatory Strategy
Develop and implement global CMC regulatory strategies for marketed products.
Support regulatory decision-making while balancing business objectives and compliance requirements.
Provide strategic guidance for lifecycle management activities across multiple regions.
Lifecycle Management (LCM)
Lead end-to-end post-approval lifecycle management activities.
Support regulatory submissions related to:
Variations
Supplements
Renewals
Annual Reports
Manufacturing Changes
Manage regulatory impact assessments for CMC changes.
Regulatory Submissions
Lead preparation and coordination of global CMC submissions.
Ensure submission packages meet regulatory requirements and timelines.
Author and review high-quality CMC documentation for worldwide submissions.
Support registrations across the US, Europe, and Rest of World (ROW) markets.
Cross-Functional Collaboration
Partner with:
Manufacturing
Quality Assurance
Quality Control
Regulatory Affairs
R&D Teams
Communicate regulatory strategies and key risks to project stakeholders.
Ensure alignment between business objectives and regulatory requirements.
Compliance & Regulatory Intelligence
Maintain current knowledge of:
FDA/CVM Guidelines
EMA Requirements
VICH Guidelines
Global Regulatory Trends
Ensure compliance with global regulatory and cGMP requirements.
Monitor evolving regulations and assess business impact.
Leadership & Mentorship
Provide training and mentorship to CMC regulatory team members.
Support capability-building initiatives within the regulatory organization.
Share best practices and regulatory expertise across teams.
Required Qualifications
Education
Bachelor's or Master's Degree in:
Pharmacy (B.Pharm / M.Pharm)
Life Sciences
Veterinary Sciences
Biotechnology
Chemistry
Related Scientific Discipline
Experience
Minimum 8 years of experience in:
Global Regulatory Affairs
CMC Regulatory Affairs
Post-Approval Lifecycle Management
Experience managing global CMC submissions and regulatory activities.
Experience supporting multiple dosage forms and manufacturing changes.
Required Skills
CMC Regulatory Affairs
Regulatory Strategy Development
Lifecycle Management (LCM)
Global Regulatory Submissions
FDA/CVM Regulations
EMA Regulations
VICH Guidelines
CMC Documentation
Variations & Supplements
Regulatory Compliance
cGMP Knowledge
Regulatory Intelligence
Stakeholder Management
Project Management
Risk Assessment
Regulatory Information Management Systems (RIMS)
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