Regulatory Affairs Specialist for Animal Health
1 week ago
About Elanco
At Elanco, we're a global leader in animal health. Our mission is to advance the health of animals, people, and the planet.
Job Summary
We're seeking a Regulatory Affairs Specialist to work with our cross-functional teams to develop regulatory strategies, oversee submission preparation, and meet reporting requirements for new animal drugs with global regulatory agencies.
About the Role
This role will execute CM&C regulatory functions necessary to provide supplements/variations, renewals, and annual reporting requirements for approved products. The ideal candidate will have a strong knowledge of FDA/CVM and EMA guidelines, as well as experience with CMC registrations in the US and/or Europe.
Key Responsibilities
- Maintain positive collaboration and partnership with internal groups in R&D, Quality, and manufacturing
- Lead CMC submission preparation to provide high-quality submissions to multiple geographies
- Proactively communicate CMC regulatory strategy, key issues, and critical topics throughout the life cycle to interdisciplinary project teams
- Author high-quality CMC documentation for submission, applying CMC global regulatory strategies, and ensuring regulatory compliance
- Stay up-to-date with regulatory guidelines and requirements in all global regions and new technical trends
Requirements
The successful candidate will have:
- 5+ years of experience in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management
- Strong communication skills, both written and oral
- Ability to make decisions when there is no clear right or wrong answer
- Self-starter, takes initiative
- Timeline-driven
- Attention to detail
- Quality and customer-focused mindset
- Strong organization and ability to multi-task; able to handle multiple projects at different phases of development simultaneously
Compensation
The estimated salary for this role is $120,000 - $150,000 per year, depending on location and experience.
About Elanco
Elanco is a global animal health company dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.
Working at Elanco
We foster a diverse and inclusive work environment, valuing diversity as the driving force behind innovation, creativity, and business success. Our employees are passionate about making a difference in the lives of animals and people.
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