Location: Bangalore, India
Application Deadline: June 30, 2025
Job ID: R0022416
About Elanco
Elanco (NYSE: ELAN) is a global leader in animal health, committed to enhancing the lives of animals through innovative products and services. With a vision of “Food and Companionship Enriching Life,” Elanco focuses on sustainability and improving the health of animals, people, and the planet.
At Elanco, diversity and inclusion drive innovation and business success. Employees collaborate in a dynamic environment, gaining valuable skills and experiences to advance their careers.
Job Description: Associate Manager – CMC Regulatory Writing
The Associate Manager, Global CMC Regulatory will collaborate with manufacturing and quality teams to develop regulatory strategies, oversee submissions, and ensure compliance with global regulatory requirements. This role involves managing post-approval submissions, supplements, renewals, and annual reports for animal health products.
Key Responsibilities:
- Design and implement CMC regulatory strategies for development projects and marketed products.
- Collaborate with R&D, Quality, and Manufacturing teams to ensure compliance.
- Lead global CMC submissions, ensuring high-quality documentation for FDA/CVM, EMA, and other regulatory bodies.
- Communicate regulatory strategies and updates to project teams.
- Author and review CMC regulatory documents for submissions.
- Stay updated on global regulatory guidelines and industry trends.
- Train and mentor CMC team members as needed.
Core Competencies:
- Strong knowledge of FDA/CVM and EMA regulations.
- Experience in CMC regulatory submissions (US/EU).
- Excellent written and oral communication skills.
- Decision-making ability in ambiguous situations.
- Strong organizational skills with the ability to manage multiple projects.
- Detail-oriented with a quality-focused mindset.
Qualifications & Experience:
- Education: MSc, B.Pharm/M.Pharm, or Postgraduate in Veterinary Sciences.
- Experience: Minimum 5+ years in Global Regulatory Affairs (Post-approval CMC Lifecycle Management preferred).
- Preferred: Knowledge of cGMP requirements and experience with Regulatory Information Management Systems.
How to Apply
Interested candidates can apply before June 30, 2025, through Elanco’s career portal.
Why Join Elanco?
- Work in a diverse and inclusive environment.
- Contribute to innovative animal health solutions.
- Career growth opportunities in a global organization.
Elanco is an Equal Opportunity Employer committed to diversity and non-discrimination based on age, race, gender, disability, or any other protected status.