Advisor - Global Regulatory Affairs CMC Biologicals

Elanco Animal Health Incorporated; Cuxhaven; On-site; EUR 90,000 - 140,000; Full time

Job summary

Elanco Animal Health Incorporated is seeking an Advisor - Global Regulatory Affairs CMC Biologicals in Germany. The role collaborates with R&D, Manufacturing, and Quality to secure and maintain registrations for biological products, including geo-expansion initiatives.

The ideal candidate brings 8+ years in Global Regulatory Affairs, fluency in English and German, and strong CMC strategy and scientific writing capabilities to ensure compliance and timely submissions.

Qualifications

• Bachelor of Science required.
• Deep knowledge of EU regulatory legislation for veterinary vaccines.
• Fluent in English and German.
• 8+ years in Global Regulatory Affairs, preferably vaccines/CMC.
• Experience in regulatory CMC strategy for Europe (EMA) and other regions.
• Strong scientific writing and communication skills.
• Ability to influence decisions in a matrix environment.

Responsibilities

• Design/develop regulatory CMC strategy for post-approval changes and geo-expansion.
• Collaborate with R&D, Manufacturing, Quality, and global regulatory partners.
• Lead CMC regulatory pre-submission preparation and communicate strategy across teams.
• Ensure documentation and timelines for global submissions are tracked.
• Author high-quality CMC regulatory documentation for submissions.
• Monitor regulatory guidelines and industry trends and share insights.

Skills

EU regulatory legislation

English and German fluency

Global Regulatory Affairs experience

CMC regulatory strategy

Scientific writing

Communication skills

Planning & organization

Cross-functional influence

Education

Bachelor of Science

Job description

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!

The role:

The purpose of the Advisor - Global Regulatory Affairs CMC Biologicals role is to work cross functionally with Elanco R&D, Manufacturing, Quality, and other Elanco departments in support of the authorization and maintenance of registrations with global regulatory agencies for the biological products.

The role also executes CMC regulatory functions necessary to support geo-expansion activities for currently registered veterinary biological products as well as new innovations in the biological space.

Your responsibilities:

• Design/develop regulatory CMC strategy for post-approval changes and geo-expansion of marketed biological products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
• Maintain a positive collaboration and partnership with internal groups in R&D, Manufacturing, Quality, and global regulatory business partners of Elanco.
• Lead CMC regulatory pre-submission preparation and proactively communicate CMC regulatory strategy, key issues and other critical topics throughout the product life cycle to interdisciplinary project teams, while applying the global strategy into submissions.
• Ensure that the required documentation and any content and/or timelines for global submissions are communicated to the appropriate teams and tracked according to the functional procedures.
• Author high‑quality CMC regulatory documentation for submission, applying global regulatory CMC strategies while assuring regulatory compliance.
• Stay abreast of changing regulatory guidelines and requirements or industry technical trends and proactively share the information within the organization.

What You Need to Succeed (minimum qualifications):

• Bachelor of Science
• Excellent understanding of EU regulatory legislation for veterinary vaccines
• Fluent in English and German
• 8+ years in Global Regulatory Affairs, preferably within vaccines, biotechnology, CMC, etc.
• Experience in developing regulatory CMC strategy for Europe (EMA) and most of the world countries is preferred.
• Excellent communication skills including scientific writing.
• Strong planning and organizational skills.
• Flexibility and adaptability to leverage new technologies.
• Ability to work cross‑functionally and influence decisions in a matrix environment.

Don't meet every single requirement? Studies have shown underrepresented 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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.