Global Labelling Strategist - Regulatory Affairs (Remote)

Parexel; Indiana (PA); Remote; USD 80,000 - 100,000; Full time

Job summary

Parexel is seeking an experienced Regulatory Affairs Consultant to join our Regulatory Affairs team. In this position, you will manage the end-to-end labeling lifecycle and drive global alignment of product information across multiple markets. This role offers the flexibility to work fully remotely or from the office.

The ideal candidate will possess a university degree in a life science discipline, have several years of experience in the biotech/pharmaceutical industry, and be knowledgeable in labelling and regulatory processes.

Qualifications

• A few years of experience in the biotech/pharmaceutical industry.
• Labelling/regulatory experience with global responsibilities.
• Experience with CCDS development and maintenance.

Responsibilities

• Manage end-to-end labeling lifecycle including assessment and maintenance.
• Provide innovation and technical expertise for regulatory compliance.
• Prepare and review labeling documents for regulatory submissions.
• Collaborate with regional regulatory teams for compliance.

Skills

Regulatory compliance

Global labelling operations

Technical expertise

Collaboration

Education

University degree in a life science discipline

Job description

Parexel is seeking an experienced Regulatory Affairs Consultant to join our Regulatory Affairs team. In this position, you will manage the end-to-end labeling lifecycle and drive global alignment of product information across multiple markets. This role offers the flexibility to work fully remotely or from the office.

The ideal candidate will possess a university degree in a life science discipline, have several years of experience in the biotech/pharmaceutical industry, and be knowledgeable in labelling and regulatory processes.