Advisor – Global Regulatory Affairs CMC Biologicals

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

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