At a Glance
- Tasks: Shape global regulatory strategies for veterinary biological products and collaborate with dynamic teams.
- Company: Elanco, a global leader in animal health dedicated to innovation and diversity.
- Benefits: Inclusive work environment, career growth opportunities, and the chance to make a real impact.
- Other info: We encourage diverse applicants; you might be the perfect fit even if you don't meet every requirement.
- Why this job: Join us to enhance animal health and contribute to meaningful innovations in the industry.
- Qualifications: Bachelor's degree in science and 8+ years in Global Regulatory Affairs.
The predicted salary is between 60000 - 80000 £ per year.
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 expansion
- Leading CMC regulatory activities and submission strategies for biological products
- Authoring high-quality CMC regulatory documentation for global submissions
- Collaborating with cross-functional teams to deliver successful regulatory outcomes
- Monitoring evolving regulatory requirements and translating them into business strategy
- Driving regulatory excellence while ensuring compliance across global markets
What You Need to Succeed (minimum qualifications):
- Bachelor's degree in a scientific discipline
- 8+ years of Global Regulatory Affairs experience within biologicals, vaccines, biotechnology or CMC
- Strong knowledge of EU veterinary vaccine regulations (EMA)
- Experience developing global CMC regulatory strategies for Europe and international markets
- Excellent scientific writing, communication and stakeholder management skills
- Ability to influence cross-functional teams in a global matrix environment
- Fluent English
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.
Advisor-R&D employer: Elanco
Elanco is an excellent employer that champions a diverse and inclusive workplace culture, making it an ideal environment for professionals seeking to make a meaningful impact in the field of quality control. Located in Liverpool, employees benefit from a collaborative atmosphere that encourages continuous improvement and offers ample opportunities for personal and professional growth, alongside the chance to engage in strategic initiatives across a global laboratory network.
StudySmarter Expert Advice🤫
We think this is how you could land Advisor-R&D
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Elanco. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Elanco.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Elanco. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Elanco is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Advisor-R&D
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Elanco!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Elanco that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Elanco!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Elanco, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Elanco
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Elanco that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Elanco’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
