Global Regulatory Strategy Director: Allergy & CV

Viatris; Washington (District of Columbia); On-site; USD 112,000 - 236,000; Full time

Job summary

Viatris is a global healthcare company seeking a Regulatory Affairs professional to lead global regulatory strategies and submissions for allergy and cardiovascular products. You will collaborate with clinical, safety, medical and commercial teams, author regulatory documents, and liaise with Health Authorities to support marketing authorizations.

The role requires strong English communication, 8+ years in regulatory with 5+ years global experience, and the ability to drive cross-functional

Qualifications

• Minimum of a Bachelor's degree; advanced degree may help but not required.
• 8+ years in regulatory with 5+ years global regulatory experience (US/EU).
• Global regulatory strategy and hands-on authoring experience.
• Strong knowledge of Allergy and Cardiovascular topics is an advantage.
• Excellent written and oral communication; ability to influence.

Responsibilities

• Develop global/regional regulatory strategies and implementation plans.
• Provide regulatory input to clinical development programs and labels.
• Coordinate with Health Authorities and internal teams to ensure compliant submissions.
• Contribute to CCDS updates and local label development as needed.
• Build relationships with stakeholders to align regulatory approaches.
• Monitor regulatory plans and report risks to senior management.
• Prepare required documentation for marketing authorizations.
• Lead or participate in meetings with regulatory agencies.

Skills

Regulatory strategy

Global/regulatory affairs

Authoring experience

Stakeholder collaboration

Regulatory negotiations

English proficiency

Project management

Office & Documentum tools

Education

Bachelor's degree

Advanced degree advantageous

Tools

Microsoft Office

Documentum

Job description

Viatris is a global healthcare company seeking a Regulatory Affairs professional to lead global regulatory strategies and submissions for allergy and cardiovascular products. You will collaborate with clinical, safety, medical and commercial teams, author regulatory documents, and liaise with Health Authorities to support marketing authorizations.

The role requires strong English communication, 8+ years in regulatory with 5+ years global experience, and the ability to drive cross-functional