Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager focuses on leading the design and development of regulatory strategy and technical documents in support of global development projects.

What the role involves

• Leading the design and development of regulatory strategy and technical documents in support of global development projects.
• Provide technical leadership to ensure timely delivery of regulatory activities and compliance.
• Lead engagements with regulatory agencies in the EU or the USA.
• Represent the regulatory viewpoint on development teams.
• Maintain effective relationships with global regulatory authorities and influence industry associations.
• Communicate project-specific risks and opportunities to internal stakeholders.

Skills and requirements

• Master’s degree or higher in veterinary medicine, biologic, infectious diseases, immunology, or a related field.
• A minimum of 10 years of experience in the animal health industry, with direct Regulatory Affairs experience with biologics/large molecule products.
• Demonstrated regulatory leadership and dossier registration experience, alongside a strong understanding of global regulatory procedures and risk assessment fundamentals.
• What will give you a competitive edge (preferred qualifications).