Regulatory Expert with Global Pharmaceutical Experience

2 godzin temu


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

Manpower Group Sp. z o.o. is a global leader in the employment services industry, operating in 82 countries and boasting over 70 years of experience.

Job Description

As a Regulatory Scientist, you will be responsible for providing crucial support to RSIL and RRL in navigating complex regulatory landscapes and optimizing product strategies.

Key responsibilities include:

  • Regulatory Strategy: Drive alignment between regional and global strategies by actively engaging in collaborative working groups and fostering strong relationships with regional stakeholders and LOCs.
  • Stakeholder Collaboration: 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.

You will also 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

To succeed in this role, you will need:

  • A Bachelor's Degree in Pharmacy, Chemistry, Medicine, or Biotechnology.
  • At least 2 years of experience in regulatory affairs within the pharmaceutical industry.
  • A general understanding of the pharmaceutical industry and regulatory environment in drug development and/or marketed products.
  • High-level knowledge of regulatory submission requirements, including procedures, timelines, and documentation.
  • The ability to interpret guidance and apply it to submissions in relevant countries.
  • An understanding of compliance requirements with the ability to influence outcomes.
  • Proficiency in English (C1 level).
  • Computer literacy, including experience with systems, databases, and relevant software.
  • Self-driven and collaborative, with experience working in multi-functional teams.
Benefits

We offer a stable job environment, international team, benefits package, and hybrid or remote job opportunities.

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