Advisor-R&D

Elanco Tiergesundheit AG; Liverpool; On-site; GBP 70,000 - 100,000; Full time

Job summary

Elanco is seeking an experienced Advisor - Global Regulatory Affairs CMC Biologicals to shape global regulatory strategies for veterinary biological products. You will work with R&D, Manufacturing, Quality and Regulatory Affairs to support post-approval changes, registrations, and market expansion.

The role requires 8+ years in Global Regulatory Affairs for biologicals/vaccines/CMC, a Bachelor's degree in a scientific discipline, and strong writing and stakeholder management.

Qualifications

• Bachelor's degree in a scientific discipline required.
• 8+ years of Global Regulatory Affairs experience in biologicals, vaccines, biotechnology or CMC.
• Strong knowledge of EU veterinary vaccine regulations (EMA).

Responsibilities

• Develop global CMC regulatory strategies for post-approval changes and market expansion.
• Lead CMC regulatory activities and submission strategies for biological products.
• Author high-quality CMC regulatory documentation for global submissions.
• Collaborate with cross-functional teams to deliver regulatory outcomes.
• Monitor evolving regulatory requirements and translate into business strategy.

Skills

Global regulatory affairs

CMC/regulatory strategy

Biologics/vaccines

Cross-functional collaboration

Scientific writing

Stakeholder management

Fluent English

Education

Bachelor's degree in a scientific discipline

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!Your role:Are you an experienced CMC Regulatory Affairs professional with a passion for biologicals and veterinary vaccines? Do you enjoy shaping global regulatory strategies and collaborating with cross-functional teams to bring innovative products to markets worldwide?We're looking for an Advisor - Global Regulatory Affairs CMC Biologicals to join our Global Regulatory Affairs team.As part of our global team, you'll play a key role in developing and executing CMC regulatory strategies for veterinary biological products throughout their lifecycle. You'll work closely with colleagues across R&D, Manufacturing, Quality and Regulatory Affairs to support post-approval changes, global registrations and international market expansion.Your responsibilities:Developing global CMC regulatory strategies for post-approval changes and market expansionLeading CMC regulatory activities and submission strategies for biological productsAuthoring high-quality CMC regulatory documentation for global submissionsCollaborating with cross-functional teams to deliver successful regulatory outcomesMonitoring evolving regulatory requirements and translating them into business strategyDriving regulatory excellence while ensuring compliance across global marketsWhat You Need to Succeed (minimum qualifications):Bachelor's degree in a scientific discipline8+ years of Global Regulatory Affairs experience within biologicals, vaccines, biotechnology or CMCStrong knowledge of EU veterinary vaccine regulations (EMA)Experience developing global CMC regulatory strategies for Europe and international marketsExcellent scientific writing, communication and stakeholder management skillsAbility to influence cross-functional teams in a global matrix environmentFluent EnglishDon’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 statusElanco 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.