Global Regulatory Labeling Strategy Lead (Remote)

Vertex Inc.; United States; Remote; USD 186,000 - 278,000; Full time

Benefits offered by this job

Total Rewards benefits

Educational assistance

Commuting subsidy

Matching charitable donations

401(k)

Job summary

Vertex is seeking a Regulatory Labeling Director to lead strategic global labeling across products, including CCDS, PI, PIL, and IFU for major markets (US, EU, GB, CA).

The role requires deep regulatory labeling expertise, leadership of labeling groups, and effective communication with regulators and internal stakeholders. Remote-Eligible with flexible work options; Vertex offers comprehensive benefits and equity opportunities.

Qualifications

• Bachelor’s degree in a relevant field; 10 years regulatory labeling experience preferred.
• Experience leading labeling development and regulator negotiation activities.
• Ability to synthesize complex concepts for diverse audiences.
• Knowledge of CCDS, PI, PIL, IFU labeling and global authorities.

Responsibilities

• Lead development and maintenance of global product labeling including CCDS and regional labeling.
• Ensure compliance with labeling governance and lead labeling groups.
• Advise stakeholders on regulatory labeling requirements and health authority interactions.
• Stay current on labeling regulations and emerging technologies.

Skills

Global labeling strategy

Regulatory negotiations

Cross-functional leadership

FDA/EMA knowledge

Regulatory labeling frameworks

Education

Bachelor’s degree

10 years regulatory affairs experience

Job description

Vertex is seeking a Regulatory Labeling Director to lead strategic global labeling across products, including CCDS, PI, PIL, and IFU for major markets (US, EU, GB, CA).

The role requires deep regulatory labeling expertise, leadership of labeling groups, and effective communication with regulators and internal stakeholders. Remote-Eligible with flexible work options; Vertex offers comprehensive benefits and equity opportunities.