Regulatory Affairs Specialist

4 tygodni temu


Warszawa, Polska myGwork Pełny etat
Regulatory Affairs Specialist

This role is with myGwork, an inclusive employer and a member of the largest global platform for the LGBTQ+ business community. The successful candidate will join the team that oversees the Human Resource (HR) aspects of regulatory initiatives across Europe, the Middle East, and Africa (EMEA).

As a Regulatory Affairs Specialist within EMEA HR Regulatory team, you will support the HR aspects of regulatory initiatives in the EMEA region, associated to regulated employee lifecycle ensuring connectivity with global regulatory activities, and supporting on governance regulatory submissions.

Key Responsibilities:

  • Support the execution of the UK Senior Manager and Certification Regime (SM&CR) and Ireland Individual Accountability Framework (IAF) as it relates to HR, including processes and procedures for the management of the Certified employee population.
  • Support the process to determine Finance Conduct Authority (FCA)/ Prudential Regulation Authority (PRA) Conduct Rule and CBI Conduct Standards breaches and prepare associated regulatory submissions.
  • Day-to-day oversight of UK Regulatory Reference request processes, working closely with team responsible for the administration of regulatory reference requests.
  • Day-to-day oversight of Conduct Review process, working closely with team responsible for the administration of process.
  • Support associated projects with HR partners to enhance, change or implement new procedures to reflect change in regulatory requirements.
  • Analyse and manipulate data to support EMEA HR Regulatory team.
  • Maintain and update relevant Standard Operating Procedures (SOPs), policies and procedures.
  • Provide ad-hoc advice from established policies and practices to HR Specialists and Generalists, other specialist functions outside of HR and members of the business on HR Regulatory issues.
  • Build and maintain proactive relationships with other internal groups including Compliance, Employee Relations, Legal and the global teams.
  • Assist in drafting responses to, regulators throughout the EMEA region as part of their supervision of the firm's compliance with applicable regulations.
  • Prepare regulatory submissions and correspondence with the firm's regulators.

Requirements:

  • At least 2 years of professional experience within regulatory/legal/compliance/HR.
  • Solid technical background with excellent data analysis and manipulation skills.
  • Ability to work well in and across diverse global teams.
  • Fluent English both written and spoken.
  • Excellent interpersonal and communications skills.
  • Ability to understand and navigate a complex regulatory environment.
  • Possess strong knowledge of the organization and ability to build and strengthen partnerships across functions and locations.
  • Maintain a sound understanding of the regulatory requirements impacting HR in the financial services sector and assist with understanding the impact on the Firm's businesses.
  • Takes initiative and is proactive in raising issues or identifying opportunities for partnership and operational excellence.


  • Warszawa, Mazovia, Polska Randstad Polska Pełny etat

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our international Regulatory Affairs Team. As a key member of our team, you will be responsible for providing Regulatory Affairs support, ensuring compliance with regulatory requirements, and maintaining accurate records.Key Responsibilities:Provide Regulatory...


  • Warszawa, Mazovia, Polska Novo Nordisk Pełny etat

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Novo Nordisk. As a key member of our Regulatory Affairs and Pharmacovigilance Team, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA).Main...


  • Warszawa, Mazovia, Polska Randstad Polska Pełny etat

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our international Regulatory Affairs Team. As a key member of the team, you will be responsible for coordinating lifecycle management procedures, ensuring timely submission of high-quality dossiers, and managing validation issues.Key Responsibilities:Coordinate...


  • Warszawa, Mazovia, Polska Randstad Polska Pełny etat

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our international team. As a key member of our Regulatory Affairs Team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the quality of our data.Key Responsibilities:Enter regulatory data into relevant systemsTrack and...


  • Warszawa, Mazovia, Polska Novo Nordisk Pełny etat

    Job Description:Novo Nordisk is seeking a highly skilled Regulatory Affairs Specialist to join our team in Poland. As a key member of our Regulatory and Pharmacovigilance Team, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA). Your main responsibilities...


  • Warszawa, Mazovia, Polska RICG Poland Sp. z o.o. Pełny etat

    Regulatory Affairs SpecialistWe are seeking a highly motivated Regulatory Affairs Specialist to join our team at RICG Poland Sp. z o.o. in a dynamic pharmaceutical company.Key Responsibilities:Ensure compliance with Polish and European regulations for pharmaceutical products, including the preparation and review of labeling, promotional materials, and other...


  • Warszawa, Mazovia, Polska Randstad Polska Pełny etat

    Job DetailsWe are seeking a skilled Regulatory Affairs Specialist to join our international team at Randstad Polska.About the RoleThe ideal candidate will have experience in regulatory affairs data management within the pharmaceutical or cosmetics industry. Strong knowledge of English and Polish is essential, with a good understanding of pharmaceutical...


  • Warszawa, Mazovia, Polska Novo Nordisk Pełny etat

    Job SummaryAs a Regulatory Affairs Specialist at Novo Nordisk, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA).Key Responsibilities:Preparing and submitting Regulatory documentation for New Drug Applications, post-marketing variations and renewal...


  • Warszawa, Mazovia, Polska Randstad Polska Pełny etat

    Are you looking for a challenging role in the pharmaceutical industry? We are seeking a highly skilled Regulatory Affairs Specialist to join our international Regulatory Affairs Team.Key responsibilities:Perform regulatory data entry activitiesTrack incoming data entry requests and follow up until completionEnter data in relevant systems based on information...


  • Warszawa, Mazovia, Polska Randstad Polska Pełny etat

    We are seeking a highly skilled Regulatory Affairs Specialist to join our international team at Randstad Polska. The ideal candidate will have experience in a similar position in the pharmaceutical or cosmetics industry and a higher education degree.Key Responsibilities:Regulatory Affairs data entry activitiesTrack incoming data entry requests and follow up...


  • Warszawa, Polska Bacteromic Sp. z o.o. Pełny etat

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Bacteromic Sp. z o.o. This is an exciting opportunity to work on groundbreaking projects and make a tangible impact on the future of healthcare.Key ResponsibilitiesPrepare technical documentation for IVDs and FDA risk classes.Conduct post-marketing...


  • Warszawa, Mazovia, Polska Boston Scientific Pełny etat

    Key Responsibilities:We are seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have 2 years of experience in a similar role, with a strong understanding of EU and non-EU regulatory requirements.Responsibilities:Plan and prioritize product notification/registration for EU and non-EU countries.Prepare and submit...


  • Warszawa, Mazovia, Polska Randstad Polska Pełny etat

    Regulatory Affairs Support OpportunityWe are seeking a highly skilled Regulatory Affairs Support professional to join our international Regulatory Affairs Team at an international pharmaceutical company.Key Responsibilities:Provide Regulatory Affairs support with the assembly, transmission, storage, and handling of regulatory information.Enter document...


  • Warszawa, Mazovia, Polska PL18 Alcon Polska Sp. z o.o. Company Pełny etat

    About the RoleWe are seeking a highly skilled Regulatory Affairs Analyst to join our team at Alcon Polska Sp. z o.o. Company. As a key member of our Regulatory Affairs EMEA team, you will play a critical role in supporting our administrative tasks, ensuring seamless coordination of payment and approvals for invoices, managing suppliers and contracts, and...


  • Warszawa, Mazovia, Polska Randstad Polska Pełny etat

    {"text":"Job Title: Regulatory Affairs Specialist (Pharmaceutical Industry)Are you looking for a role that combines your passion for regulatory affairs with your experience in the pharmaceutical industry?We are currently seeking a Regulatory Affairs Specialist to join our team at Randstad Polska.Employment contract for 12 months with the possibility of...

  • Regulatory Affairs Expert

    2 tygodni temu


    Warszawa, Mazovia, Polska Randstad Polska Pełny etat

    Job DescriptionIntroductionRandstad Polska is seeking an experienced Regulatory Affairs Specialist to join their international Regulatory Affairs Team. The successful candidate will be responsible for coordinating lifecycle management procedures and ensuring timely submission of high-quality dossiers.Key ResponsibilitiesCoordinate lifecycle management...


  • Warszawa, Mazovia, Polska Parexel Pełny etat

    Parexel is seeking a Regulatory Affairs Associate (Labelling) to support our team.The successful candidate will be responsible for managing and coordinating text and artwork changes, ensuring compliance with regulatory requirements and global labeling standards.Key Responsibilities:Track the status of ongoing changes to labelling/artwork projects, evaluating...


  • Warszawa, Mazovia, Polska RICG Poland Sp. z o.o. Pełny etat

    Regulatory Affairs Specialist RoleWe are seeking a highly motivated individual with a background in Polish and European regulatory law to support our team in delivering high-quality pharmaceutical products.Key Responsibilities:Ensure compliance with Polish and European regulations for pharmaceutical products.Liaise with internal departments and external...


  • Warszawa, Mazovia, Polska Allegro sp. z o.o. Pełny etat

    Role OverviewAllegro sp. z o.o. is seeking a dedicated Regulatory Affairs Specialist to monitor, analyze, and engage with EU and Polish legislation related to product safety, sustainability, and consumer empowerment for the green transition.Key ResponsibilitiesAnalyze legislation in the area of sustainability and product safety to share insights with...


  • Warszawa, Mazovia, Polska Parexel Pełny etat

    Work with Us to Shape the Future of Clinical ResearchParexel, a leading Clinical Research Organization, is currently seeking a skilled and detail-oriented Regulatory Affairs Associate (Labelling) to join our team.As a Regulatory Affairs Associate, you will be responsible for managing and coordinating text and artwork changes, ensuring compliance with...