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Viatris

Director, Regulatory Strategist

Viatris

. Provide strategic regulatory guidance using innovative regulatory approaches for assigned projects/products .

Posted 11/4/2026full-timeRemote • United Kingdom, IrelandLeadWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates extensive knowledge of global and regional regulatory environments, with proven experience in managing regulatory strategies and submissions for complex products. Capable of leading cross-functional teams and effectively communicating with Health Authorities to ensure compliance and successful product lifecycle management.

Highest-signal resume keywords
Global Regulatory Strategy DevelopmentRegulatory Submission ManagementHealth Authority NegotiationCross-Functional CollaborationRegulatory Compliance Monitoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory Strategy DevelopmentRegulatory Submission PreparationDrug Development Lifecycle ManagementRegulatory Due DiligenceComplex Regulatory Issue Management
Soft Skills
Strong Written CommunicationStrong Verbal CommunicationStrategic ThinkingRelationship Building
Certifications & Qualifications
B.S. Scientific DegreeAdvanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.)Business Qualification (DMS, MBA)
Industry Keywords
Regulatory EnvironmentHealth AuthoritiesMarketing AuthorizationsProduct DevelopmentPost-Marketing Lifecycle Management

About the role

Key responsibilities & impact
  • Provide strategic regulatory guidance using innovative regulatory approaches for assigned projects/products
  • Develop and implement global regulatory strategies for complex products/projects
  • Manage preparation and submission of correspondence and applications to regulatory agencies
  • Organize, lead, or participate in meetings with regulatory agencies
  • Ensure quality expectations are met for submissions and Health Authority interactions
  • Direct and/or facilitate communications with Health Authorities alongside regulatory local/regional partners
  • Lead global Regulatory Teams for assigned projects/products
  • Develop global/regional regulatory strategies and implementation plans
  • Partner with cross-functional project teams as Regulatory Point of Contact
  • Partner with clinical, safety, and medical teams on product development and maintenance activities
  • Contribute to Target Product Label and CCDS development and updates
  • Drive regulatory contributions and submission packages, including meeting requests, dossier sections, and query responses
  • Monitor regulatory plans, communicate progress to senior leadership, and mitigate risks
  • Build working relationships with Health Authority contacts
  • Support regulatory due diligence for business development opportunities
  • Assess evolving global and regional regulations and their impact on products/projects
  • Ensure regulatory requirements and commitments are met for Marketing Authorizations
  • Implement regulatory standards, systems, processes, and productivity improvements

Requirements

What you’ll need
  • B.S. Scientific Degree required
  • Relevant Global and/or Regional regulatory experience
  • Extensive knowledge of the regulatory environment and ability to leverage this to impact regulatory strategy development and implementation
  • Proven experience managing global and/or regional regulatory and registration activities in drug development and/or post-marketing lifecycle management
  • Ability to manage complex regulatory issues
  • Experience managing multiple products simultaneously and different stages of the product lifecycle is highly desirable
  • Proven ability to deliver to time, cost, and quality standards
  • Proven ability to partner successfully with Regulatory, Commercial, Safety, Medical, other cross functional partners and senior stakeholders
  • Proven track record negotiating with major Health Authorities, including leading such interactions
  • Demonstrated strategic thinking and ability to integrate strategies into actionable plans
  • Proven ability to deliver in a highly matrixed organization
  • Strong written and verbal communication skills
  • Strong track record demonstrating extensive depth and breadth of regulatory strategy, enabling a leadership role with minimal supervision
  • Advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or business qualification (DMS, MBA) may be an advantage but is not essential

Benefits

Comp & perks
  • Competitive salaries
  • Benefits
  • Inclusive environment
  • Equal opportunity employment