Senior Regulatory Affairs Manager
Elanco
Utrecht
2 days ago
Senior Regulatory Affairs Manager
Senior Regulatory Affairs Manager needed at Elanco in Utrecht to lead regulatory strategy for animal health products. Requires 10+ years of animal health industry experience with biologics regulatory affairs.
On-site
Full-time
Senior
Regulatory Affairs
Biologics
Salary
Not specified
Core Qualifications
Technical (Must-have)
Regulatory AffairsBiologicsLarge molecule productsDossier registrationRisk assessment
Soft Skills
Interpersonal skillsCommunication skillsInfluenceDiplomatically challenge
Preferred Qualifications
Technical (Nice-to-have)
Novel regulatory pathways
Key Responsibilities
- Lead the design and development of regulatory strategy and technical documents in support of global development projects.
- Manage resources and provide technical leadership to ensure timely delivery of regulatory activities and compliance.
- Represent the regulatory viewpoint on development teams and lead engagements with regulatory agencies in the EU or the USA.
- Develop and maintain effective relationships with global regulatory authorities and influence industry associations.
- Proactively identify and communicate project-specific risks and opportunities to internal stakeholders.
Regulatory AffairsAnimal HealthBiologicsSenior ManagerUtrechtPharmaceuticalFull-timeOn-site