Remote Pharma Labeling Strategy Director

The Fountain Group; Gaithersburg (MD); Remote; USD 83,000 - 96,000; Full time

Job summary

The Fountain Group is seeking a Labelling Strategy Associate Director to provide regulatory labeling expertise for complex drug projects. You will lead development and maintenance of Core Product Information and MPI for US/EU markets, guiding cross-functional PLT teams toward compliant and advantageous labeling.

The role requires hands-on labeling experience, 3+ years in regulatory labeling, and strong collaboration across US, Europe, and IG partners.

Qualifications

• Hands-on strategic labeling experience.
• 3+ years in regulatory pharmaceutical labeling strategy.
• Ability to hit the ground running on core labeling concepts.
• Experience collaborating with international teams.
• Background in GxP-regulated pharma environment.

Responsibilities

• Lead development and maintenance of Core Product Information and MPI.
• Develop labeling strategy aligned with regulatory guidelines.
• Coordinate with GRST/GRET/PLT for CPI, US PI, EU QRD.
• Provide labeling guidance to stakeholders and communicate regulatory updates.
• Mentor peers and contribute to labeling policies and SOPs.
• Ensure labeling processes comply with procedures and GxPs.

Skills

Strategic labeling

Regulatory labeling

Cross-functional collaboration

Education

Bachelor’s Degree in Science or related discipline

Tools

ERV (Veeva Vault)

Job description

The Fountain Group is seeking a Labelling Strategy Associate Director to provide regulatory labeling expertise for complex drug projects. You will lead development and maintenance of Core Product Information and MPI for US/EU markets, guiding cross-functional PLT teams toward compliant and advantageous labeling.

The role requires hands-on labeling experience, 3+ years in regulatory labeling, and strong collaboration across US, Europe, and IG partners.