CMC Regulatory Scientist: Global Submissions & Strategy

Johnson & Johnson; Warszawa; On-site; PLN 211,000 - 296,000; Full time

Job summary

A global healthcare company is seeking a Senior Scientist in CMC Regulatory Affairs located in Warsaw, Poland. The role involves developing and managing global regulatory strategies and submissions for pharmaceutical products. Candidates should have a background in engineering, biology, or related fields with 3-6 years of experience. Strong communication skills and an understanding of drug development are essential. Join us to contribute to impactful healthcare solutions.

Qualifications

• A minimum of 3-6 years of experience in regulatory affairs or pharmaceutical industry.
• Good verbal and written communication skills.
• Proficient understanding of relevant biological or chemical sciences.

Responsibilities

• Assist in executing global regulatory strategy for products.
• Support global regulatory filings and submissions.
• Prepare dossiers for Health Authorities submissions.

Skills

Analytical Reasoning

Coaching

Communication

Consulting

Controls Compliance

Corporate Governance

Critical Thinking

Data Governance

Drug Discovery Development

Healthcare Trends

Public Policies

Regulatory Compliance

Regulatory Development

Relationship Building

Risk Compliance

Scientific Research

Technical Writing

Technologically Savvy

Education

BS in engineering, biology, pharmaceutical or chemical sciences

MS., PhD, or Pharm. D. degrees

Job description

A global healthcare company is seeking a Senior Scientist in CMC Regulatory Affairs located in Warsaw, Poland. The role involves developing and managing global regulatory strategies and submissions for pharmaceutical products. Candidates should have a background in engineering, biology, or related fields with 3-6 years of experience. Strong communication skills and an understanding of drug development are essential. Join us to contribute to impactful healthcare solutions.