Regulatory Affairs Expert

7 godzin temu


Warszawa, Mazovia, Polska ManpowerGroup Sp. z o.o. Pełny etat

ManpowerGroup Sp. z o.o., a global leader in the employment services industry, is seeking an experienced Regulatory Affairs Expert to join our team. Our company has over 70 years of experience, operating in 82 countries, with a presence in Poland since 2001. We strive to provide job seekers with new opportunities, helping them find employment that matches their qualifications and experience.

Key Responsibilities:
  • Regulatory Strategy: Provide crucial support to RSIL and RRL in navigating complex regulatory landscapes and optimizing product strategies
  • Stakeholder Collaboration: Drive alignment between regional and global strategies by actively engaging in collaborative working groups and fostering strong relationships with regional stakeholders and LOCs
  • Documentation and Processes: Lead the development of streamlined regulatory submission processes and ensure meticulous review and management of regulatory documents, ensuring adherence to strict timelines and high-quality standards
  • Clinical Trials: Offer expert guidance on CTA documents and deliver operational excellence in managing the assembly and submission of clinical trial applications, ensuring seamless execution of regulatory requirements
  • Marketing Authorization: Play a pivotal role in supporting registration processes and maintaining dossier readiness, overseeing the preparation and submission of regulatory documentation with precision and efficiency
  • General Support: Provide invaluable regulatory insight and support, ensuring compliance with regulatory standards, and representing Regulatory in cross-functional teams, while staying abreast of evolving regulatory landscapes
Requirements:
  • Bachelor's Degree: In Pharmacy, Chemistry, Medicine, or Biotechnology
  • Experience: 2+ years in regulatory affairs within the pharmaceutical industry
  • Industry Knowledge: General understanding of the pharmaceutical industry and regulatory environment in drug development and/or marketed products
  • Regulatory Submission Requirements: High-level knowledge of regulatory submission requirements, including procedures, timelines, and documentation
  • Guidance Interpretation: Ability to interpret guidance and apply it to submissions in relevant countries
  • Compliance: Understanding of compliance requirements with the ability to influence outcomes
  • Language: Proficiency in English (C1 level)
  • Computer Literacy: Self-driven and collaborative, with experience working in multi-functional teams


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