CMC Regulatory Affairs Consultant — Life Sciences

SciencePharma; Warszawa; On-site; PLN 180,000 - 280,000; Full time

Job summary

SciencePharma's CMC Regulatory Affairs team seeks a skilled professional to support development, registration, and lifecycle management of medicinal products. You will prepare and review CMC documentation for regulatory submissions across development and commercial products, interact with Health Authorities, and ensure GMP documentation compliance.

English fluency and a strong track record of 4+ years in CMC regulatory affairs are essential as you collaborate with clients and internal teams on

Qualifications

• Minimum 4 years of experience in CMC Regulatory Affairs, pharmaceutical development, manufacturing, quality assurance, or related area.
• Strong knowledge of CMC requirements for development, registration and lifecycle management of medicinal products.
• Fluency in English, both written and spoken.

Responsibilities

• Provide solutions and expert support related to the development and registration of medicinal products.
• Prepare, review and deliver CMC documentation for regulatory submissions covering both development-stage and commercial products.
• Support clients in resolving CMC-related matters and responding to Health Authority questions and requests.
• Ensure timely delivery of high-quality projects in compliance with regulatory requirements, scope and budget.
• Collaborate with clients and internal teams to facilitate successful project execution.
• Provide technical expertise in drug substance and drug product development and lifecycle management across the product lifecycle, including clinical development, MA, and post-approval variations.
• Review GMP documentation related to manufacturing sites for medicinal products.
• Verify manufacturing documentation, including batch records.
• Participate in projects involving pharmaceutical development, regulatory submissions, and lifecycle management activities.

Skills

CMC Regulatory Affairs

Regulatory submissions

English fluency

Project management

Education

Master's degree in Pharmacy

Job description

SciencePharma's CMC Regulatory Affairs team seeks a skilled professional to support development, registration, and lifecycle management of medicinal products. You will prepare and review CMC documentation for regulatory submissions across development and commercial products, interact with Health Authorities, and ensure GMP documentation compliance.

English fluency and a strong track record of 4+ years in CMC regulatory affairs are essential as you collaborate with clients and internal teams on