Remote Principal Consultant - Regulatory Labeling Strategy

Dennis Partners; United States; Remote; USD 240,000 - 275,000; Full time

Benefits offered by this job

Quarterly bonus program

Comprehensive employee benefits

Remote work flexibility

Job summary

A niche regulatory consulting firm is seeking a Regulatory Labeling Strategy Principal Consultant to manage and execute labeling strategies for biotech and pharmaceutical clients. This remote position offers a competitive salary between $240,000 and $275,000, along with comprehensive benefits. Candidates should have a scientific background, a minimum of 6 years in regulatory affairs, and a deep understanding of U.S. and EU regulations. Occasional travel for client meetings is expected.

Qualifications

• Must have a minimum of 6 years of experience in pharmaceutical regulatory affairs specializing in Labeling Strategy.
• Understanding of end-to-end labeling process and systems.
• Experience with CCDS, SmPC and USPI.

Responsibilities

• Daily management of regulatory requirements for labeling strategy for one or more client projects.
• Design and implement labeling strategy and provide leadership for consensus.
• Lead preparation, review, and update content for labeling components.

Skills

Pharmaceutical regulatory affairs expertise

Labeling strategy development

Project management skills

Knowledge of US and EU regulations

Collaboration with clients

Education

Bachelors in a scientific discipline

Advanced degree (MS, MD, PharmD, or PhD)

Job description

A niche regulatory consulting firm is seeking a Regulatory Labeling Strategy Principal Consultant to manage and execute labeling strategies for biotech and pharmaceutical clients. This remote position offers a competitive salary between $240,000 and $275,000, along with comprehensive benefits. Candidates should have a scientific background, a minimum of 6 years in regulatory affairs, and a deep understanding of U.S. and EU regulations. Occasional travel for client meetings is expected.