Global Regulatory Affairs (CMC) Advisor – Biological Vaccines

Elanco; De Kiel; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

Elanco is seeking an Advisor for Global Regulatory Affairs CMC Biologicals to lead regulatory CMC strategy across post-approval changes and geo-expansion. You will collaborate with R&D, Manufacturing, Quality, and regulatory partners to support registrations and lifecycle management of biological products.

The role requires a science degree, deep EU vaccine regulation knowledge, and fluency in English and German.

Formación

• Broad understanding of EU regulatory legislation for veterinary vaccines.
• Experience leading CMC regulatory strategy for post-approval changes.
• Ability to communicate complex regulatory concepts clearly in writing and in meetings.
• Proven ability to work cross-functionally in a matrix environment.
• Experience with EMA submissions and global regulatory interactions.

Responsabilidades

• 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.

Conocimientos

Regulatory strategy

Cross-functional collaboration

Scientific writing

Project management

English/German fluency

Educación

Bachelor of Science

Descripción del empleo

Elanco is seeking an Advisor for Global Regulatory Affairs CMC Biologicals to lead regulatory CMC strategy across post-approval changes and geo-expansion. You will collaborate with R&D, Manufacturing, Quality, and regulatory partners to support registrations and lifecycle management of biological products.

The role requires a science degree, deep EU vaccine regulation knowledge, and fluency in English and German.