At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Your role:
The purpose of the Manager - CMC Regulatory is to work cross-functionally with Elanco R&D groups, manufacturing, and quality to develop global regulatory strategies, oversee submission preparation, and meet reporting requirements for the Authorization and Maintenance of registrations for new animal drugs with global regulatory agencies.
The role executes CMC regulatory functions necessary to support renewals and annual reporting requirements for approved veterinary drug products, including biocides, pesticides, and sterile injectables. The candidate must possess strong knowledge ofFDA(CVM),EPA,USDA(CVB), andEMAregulations, alongsideICH/VICHguidelines governing the authorization and post-approval compliance of Veterinary Medicinal Products.
Your Responsibilities:
Life Cycle Management (LCM):Proven track record of overseeing end-to-end LCM of diverse pharmaceutical dosage forms, including otic solutions/suspensions, spot-on/pour-on solutions, collars, bee-hive strips, sterile injectables, and products derived from biotechnology/fermentation processes.
Regulatory Strategy:Design and develop CMC regulatory strategies for the geo-expansion of marketed products, focusing on innovation and maximizing business benefit while maintaining regulatory compliance.
Collaboration:Maintain positive partnerships with internal R&D, Quality, and Manufacturing groups, as well as global regulatory business partners.
Submission Leadership:Lead CMC pre-submission preparation and proactively communicate strategies and critical issues to interdisciplinary project teams.
Documentation & Compliance:Author high-quality CMC documentation for submissions and ensure all content, quality, and timelines are tracked according to functional procedures.
Knowledge Management:Keep knowledge up to date regarding global regulatory guidelines and new technical trends.
Mentorship:Provide training and mentorship to CMC team members as necessary.
Core Competencies
Regulatory Expertise:Strong knowledge ofFDA(CVM),EPA,USDA(CVB),EMA, andICH/VICHguidelines for biocides, pesticides, topical products, and biotechnology products intended for veterinary use.
Strategic Experience:Experience in developing CMC Regulatory Strategy for complex dosage forms (sterile preparations, biotech products) and topical forms (collars, spot-ons) in the US, Europe, and global markets.
Soft Skills:Strong written and oral communication; ability to make decisions in ambiguous situations; self-starter with high initiative.
Operational Excellence:Timeline-driven, attention to detail, and a quality/customer-focused mindset.
Organization:Ability to handle multiple projects at different development phases simultaneously.
What You Need to Succeed (minimum qualifications):
Degree in Science (BSc; MSc, B.Pharm/M.Pharm, Postgraduate in Vet Sciences etc.,)
Minimum Experience:
5+ years in Global Regulatory Affairs
Additional Information:
Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
