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Regulatory Affairs Expert with Pharmaceutical Industry Knowledge

1 miesiąc temu

Warszawa, Mazovia, Polska Parexel Pełny etat
About the Role

Parexel Consulting is seeking a skilled Regulatory Affairs Consultant to join our team. As a key member of our multinational pharmaceutical company, you will play a crucial role in ensuring the effective planning, review, and preparation of CMC components for investigational new drugs, new drug license applications, progress reports, amendments, supplemental applications, and maintenance of approved marketed products.

Key Responsibilities
  • Assist in the technical review and preparation of investigational drug applications, marketing applications, and other reports for submission to regulatory agencies.
  • Ensure that documents meet established regulatory requirements in terms of content and structure.
  • Serve as a liaison between various functional groups, program teams, international regulatory bodies, and business partners, proposing solutions based on your technical experience and identifying potential project timeline delays.
  • Maintain Regulatory CMC documentation.
  • Manage related databases and submission schedules.
  • Assist in the development of submission plans and project timelines.
  • Prepare for and interact with regulatory agencies during drug submissions, responding to inquiries, and participating in regulatory agency inspections.
Requirements
  • University degree in a scientific field
  • At least 5 years of relevant experience in the pharmaceutical industry or a regulatory authority
  • Successful experience in delivering CMC sections of marketing authorizations, investigational drugs, and life cycle management of commercial products.
  • Knowledge of EMA guidance, regulations, and ICH/GMP requirements.
  • Previous regulatory experience with small molecule
  • Experience with EU submissions via the Centralised Procedure and national procedures.
  • Experience with extension applications for new strengths and/or pharmaceutical dosage forms.
  • Ability to work independently and within project teams or committees, demonstrating accountability in achieving group goals and key project milestones.
  • Fluent in English written and spoken
Compensation and Benefits

The estimated annual salary for this position is €80,000 - €110,000, depending on experience and qualifications. Additionally, Parexel offers a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.