Regulatory Scientist

4 tygodni temu

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

Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę


Main 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
  • 2+ years of experience in regulatory affairs within the pharmaceutical industry
  • 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
  • Ability to interpret guidance and apply it to submissions in relevant countries
  • 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
  • Attention to detail and exceptional organizational skills
Offer:
  • Opportunity to work for a global Big Pharma company
  • Stable job environment
  • International team
  • Benefits package
  • Hybrid or remote job

The offer applies to permanent work.

  • Regulatory Scientist

    6 dni temu

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

    Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i...

  • SERM Principal Scientist

    3 tygodni temu

    Warszawa, Mazovia, Polska GSK Pełny etat

    Standort: WarsawDatum: May Safety Evaluation & Risk Management, Principal ScientistProvides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety...

  • SERM Principal Scientist

    2 miesięcy temu

    Warszawa, Mazovia, Polska GSK Pełny etat

    Standort: WarsawDatum: May Safety Evaluation & Risk Management, Principal ScientistProvides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety...

  • Medical and Scientific Affairs Senior Scientist

    6 dni temu

    Warszawa, Mazovia, Polska 12639 GSK Consumer Healthcare Singapore Pte. Ltd. Pełny etat

    Medical and Scientific Affairs Senior Scientist (Poland, Ukraine, CIS) page is loaded Medical and Scientific Affairs Senior Scientist (Poland, Ukraine, CIS) Apply locations Warsaw time type Full time posted on Posted 5 Days Ago job requisition id Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're...

  • SERM Principal Scientist

    3 tygodni temu

    Warszawa, Mazovia, Polska GSK Pełny etat

    Nome della sede: WarsawData di apertura: May Safety Evaluation & Risk Management, Principal ScientistProvides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.Ensures scientifically sound review and interpretation of data and management of safety issues and...

  • SERM Principal Scientist

    2 miesięcy temu

    Warszawa, Mazovia, Polska GSK Pełny etat

    Nome della sede: WarsawData di apertura: May Safety Evaluation & Risk Management, Principal ScientistProvides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.Ensures scientifically sound review and interpretation of data and management of safety issues and...

  • SERM Principal Scientist

    3 tygodni temu

    Warszawa, Mazovia, Polska GSK Pełny etat

    Site Name: WarsawPosted Date: May Safety Evaluation & Risk Management, Principal ScientistProvides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.Ensures scientifically sound review and interpretation of data and management of safety issues and escalates...

  • SERM Principal Scientist

    4 tygodni temu

    Warszawa, Mazovia, Polska GSK Pełny etat

    Site Name: WarsawPosted Date: May Safety Evaluation & Risk Management, Principal ScientistProvides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.Ensures scientifically sound review and interpretation of data and management of safety issues and escalates...

  • SERM Principal Scientist

    6 dni temu

    Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etat

    Site Name: WarsawPosted Date: May Safety Evaluation & Risk Management, Principal ScientistProvides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.Ensures scientifically sound review and interpretation of data and management of safety issues and escalates...

  • Medical and Scientific Affairs Senior Scientist

    6 dni temu

    Warszawa, Mazovia, Polska Haleon Pełny etat

    Hello. We're Haleon.A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep...

  • Medical And Scientific Affairs Senior Scientist

    6 dni temu

    Warszawa, Mazovia, Polska Haleon Pełny etat

    Hello.We're Haleon.A new world-leading consumer health company.Shaped by all who join us.Together, we're improving everyday health for billions of people.By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren , Theraflu, Otrivin , and Centrum – through a unique combination of deep human...

  • Compliance AML Core Officer

    6 dni temu

    Warszawa, Mazovia, Polska 11101 Citibank Europe plc Poland Pełny etat

    As a Data Scientist & Compliance Officer, you will have a crucial role in using data analytics to ensure compliance with AML regulatory requirements and promoting data-driven decision-making throughout the Detection Risk Coverage Organization. You will collaborate with different teams to create and execute data-driven solutions that strengthen compliance...

  • Compliance AML Core Officer

    6 dni temu

    Warszawa, Mazovia, Polska Citigroup Inc. Pełny etat

    As a Data Scientist & Compliance Officer, you will play a critical role in leveraging data analytics to ensure compliance with AML regulatory requirements while also driving data-driven decision-making across the Detection Risk Coverage Organization. You will work closely with cross-functional teams to develop and implement data-driven solutions that not...

  • Senior Scientist, Biostatistics

    6 dni temu

    Warszawa, Mazovia, Polska AstraZeneca Pełny etat

    Location: Barcelona, Spain; Warsaw, PolandCompetitive Salary & BenefitsMake a more significant impact on patients' lives worldwideGet ready to play a crucial role in improving patients' lives. This is where scientific breakthroughs turn into life-changing medications for the most challenging diseases out there. Address unmet medical needs through...

  • Associate Director

    6 dni temu

    Warszawa, Mazovia, Polska AstraZeneca Pełny etat

    At AstraZeneca, we focus on fostering a collaborative culture that promotes knowledge-sharing, ambitious thinking, and innovation - giving employees the chance to work across teams, functions, and even the globe.Our working methods prioritize individual flexibility, allowing employees to balance personal and work commitments while maintaining a culture of...