CMC & Regulatory Affairs Specialist — Hybrid (Warsaw/Madrid)

QbD Group; Warszawa; Híbrido; PLN 180.000 - 280.000; Jornada completa

Descripción de la vacante

QbD Group is seeking a Regulatory Affairs professional to support development and registration of medicinal products in a hybrid Warsaw/Madrid/Barcelona setup. You will prepare and deliver CMC documentation for regulatory submissions and advise clients on CMC matters.

You will collaborate with clients and internal teams, ensure regulatory compliance, and contribute to lifecycle management across pharma and biotech projects. Fluent English and independent work style are essential.

Formación

• Master's degree in Pharmacy, Chemistry, Biotechnology, Pharmaceutical Sciences, Life Sciences, or related field.
• 4+ years of experience in CMC Regulatory Affairs or related areas.
• Strong knowledge of CMC requirements for development, registration and lifecycle management.
• Fluency in English (written and spoken).
• Excellent communication and organizational skills.
• Ability to work independently and manage multiple activities.

Responsabilidades

• Provide solutions and expert support related to development and registration of medicinal products.
• Prepare, review, and deliver CMC documentation for regulatory submissions.
• Support clients in resolving CMC-related matters and respond to Health Authority requests.
• Ensure timely delivery of high-quality projects in compliance with regulatory requirements, scope and budget.
• Collaborate with clients and internal teams to facilitate project execution.
• Provide technical expertise in drug substance and drug product development and lifecycle management for regulatory submissions.
• 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.

Conocimientos

CMC Regulatory Affairs

Regulatory submissions

English fluency

Communication

Independent work

Project collaboration

Educación

Master's degree in Pharmacy

Descripción del empleo

QbD Group is seeking a Regulatory Affairs professional to support development and registration of medicinal products in a hybrid Warsaw/Madrid/Barcelona setup. You will prepare and deliver CMC documentation for regulatory submissions and advise clients on CMC matters.

You will collaborate with clients and internal teams, ensure regulatory compliance, and contribute to lifecycle management across pharma and biotech projects. Fluent English and independent work style are essential.