Advisor – Global Regulatory Affairs CMC Biologicals

Elanco; Monheim; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Elanco in Monheim, Germany is seeking an Advisor – Global Regulatory Affairs CMC Biologicals to work cross‑functionally with R&D, Manufacturing and Quality to support the authorization and ongoing registration of biological products. You will lead CMC regulatory strategies for post‑approval changes and geo‑expansion, prepare submissions, and ensure timelines are met while tracking regulatory trends.

The role requires a B.S., 8+ years in Global Regulatory Affairs, and fluency in English and

Qualifikationen

• Bachelors degree required.
• 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
• Experience in developing regulatory CMC strategy for Europe (EMA) and other regions
• Excellent communication and scientific writing skills
• Strong planning and organizational skills
• Ability to work cross-functionally in a matrix environment

Aufgaben

• Design/develop regulatory CMC strategy for post-approval changes and geo-expansion of marketed biological products.
• Maintain collaboration with R&D, Manufacturing, Quality, and regulatory partners.
• Lead CMC regulatory pre-submission preparation and communicate strategy and issues to project teams.

Kenntnisse

English (Fluent)

German (Fluent)

Regulatory affairs

Regulatory writing

Ausbildung

Bachelor of Science

Jobbeschreibung

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 the 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.