Remote Biologics Strategy & Compliance Consultant

Pharmavise Corporation; Poland; Remote; PLN 180,000 - 360,000; Full time

Job summary

Pharmavise Consulting Corp. is seeking a seasoned Consultant/Biologics to advise clients in biologics development, manufacturing, and regulatory affairs. This is a fully remote role with global exposure and frequent collaboration with life science teams.

You will conduct gap analyses, develop regulatory strategies (CMC, INDs, BLAs), support submissions, and prep clients for agency interactions. A PhD/MS and 5+ years in biopharma are required, with travel as needed.

Qualifications

• Advanced degree in a scientific or engineering discipline.
• Minimum 5 years in biopharma with biologics development, manufacturing, or regulatory affairs.
• Strong expertise in biologics development, upstream/downstream processing, analytics.
• Deep understanding of FDA/EMA/ICH regulations for biologics.
• Proven consulting or project management experience with client outcomes.

Responsibilities

• Provide expert consulting on biologics development, manufacturing, and regulatory affairs.
• Align with clients to identify needs and develop tailored regulatory solutions.
• Conduct gap analyses of biologics programs to drive improvements.
• Develop regulatory strategy, CMC plans, and lifecycle management initiatives.
• Support regulatory submissions including INDs, BLAs, and variations.
• Prepare clients for agency meetings and inspections.
• Stay current on biologics regulatory trends and best practices.
• Travel as needed to meet client requirements.

Skills

Biologics development

Regulatory affairs

Consulting

Communication skills

Analytical thinking

Travel willingness

Cross-functional collaboration

Education

PhD or MS in biochemistry/biotechnology/pharmaceutical sciences

Job description

Pharmavise Consulting Corp. is seeking a seasoned Consultant/Biologics to advise clients in biologics development, manufacturing, and regulatory affairs. This is a fully remote role with global exposure and frequent collaboration with life science teams.

You will conduct gap analyses, develop regulatory strategies (CMC, INDs, BLAs), support submissions, and prep clients for agency interactions. A PhD/MS and 5+ years in biopharma are required, with travel as needed.