Regulatory Operations Manager

3 tygodni temu

Lublin, Lubelskie, Polska Pharmiweb Pełny etat
Job Title: Manager, Regulatory Operations

About the Role:

We are seeking a highly skilled Manager, Regulatory Operations to join our team at ICON. As a key member of our regulatory operations team, you will be responsible for leading the development and implementation of regulatory strategies and processes to ensure compliance with global regulatory requirements.

Key Responsibilities:

* Lead the development and implementation of regulatory strategies and processes to ensure compliance with global regulatory requirements
* Manage eCTD submissions, ensuring they are tracked accurately and in full compliance with regulatory guidelines
* Develop internal processes for eCTD and CTIS
* Recruit and train regulatory personnel for eCTD and CTIS submissions
* Oversee the global publishing, compilation, filing, and maintenance of regulatory submissions
* Maintain positive and productive relationships with internal and external stakeholders, including regulatory agencies, clients, colleagues, and staff

Requirements:

* Bachelor's degree or equivalent experience in a relevant field
* Proven experience working with eCTD submissions
* Demonstrated ability to produce high-quality work with strong attention to detail
* Experienced in creating and delivering effective training materials
* Strong leadership skills with the ability to support and guide team members with both compassion and confidence

About ICON:

At ICON, we are committed to providing a workplace free of discrimination and harassment. We are an equal opportunities employer and welcome applications from all qualified candidates. If you are interested in this role, please submit your application. We look forward to hearing from you.

Benefits:

We offer a range of benefits to our employees, including competitive salary, annual bonuses, health-related benefits, and retirement plans. We also provide opportunities for professional development and growth within the company.

What We Offer:

* Competitive salary and annual bonuses
* Health-related benefits and retirement plans
* Opportunities for professional development and growth
* A dynamic and supportive work environment

How to Apply:

If you are interested in this role, please submit your application. We look forward to hearing from you.

Contact Information:

If you have any questions or would like to discuss this role further, please do not hesitate to contact us.

Equal Opportunities Employer:

At ICON, we are committed to providing a workplace free of discrimination and harassment. We are an equal opportunities employer and welcome applications from all qualified candidates.

  • Internal Audit Manager

    3 tygodni temu

    Lublin, Lubelskie, Polska LeasingTeam Group Pełny etat

    Job Title: Internal Audit ManagerLeasingTeam Group is seeking an experienced Internal Audit Manager to join our team. As a key member of our Internal Audit department, you will be responsible for ensuring the effectiveness of our internal controls and risk management processes.Key Responsibilities:Develop and implement internal audit plans to ensure...

  • Internal Audit Manager

    1 tydzień temu

    Lublin, Lubelskie, Polska LeasingTeam Group Pełny etat

    LeasingTeam Group is seeking a seasoned Internal Audit Manager to support our clients in maintaining a strong control environment.About the RoleEnsure that the control framework is consistent with regulatory requirements and best practiceResponsibilitiesMaintenance of the change management process by assistance in evaluation of business and IT process...

  • Internal Audit Manager

    2 tygodni temu

    Lublin, Lubelskie, Polska LeasingTeam Group Pełny etat

    LeasingTeam Group is looking for an experienced Internal Audit Manager to join their team.Key Responsibilities:Ensure that the control framework is consistent with best practices and regulatory requirements.Maintenance of the change management process by evaluating business and IT process changes to identify financial risks and their probable...

  • Site Management Associate

    3 tygodni temu

    Lublin, Lubelskie, Polska Pharmiweb Pełny etat

    Job SummaryWe are seeking a highly skilled Site Management Associate to join our team at Pharmiweb. As a key member of our clinical research operations team, you will be responsible for ensuring the successful delivery of clinical trials from start to finish.Key ResponsibilitiesManage and maintain study systems and tracking tools to ensure quality,...

  • Automotive Finance Test Manager with German Language Skills

    2 tygodni temu

    Lublin, Lubelskie, Polska Trimetis Services Pełny etat

    About the RoleWe are seeking a skilled Test Manager to oversee the testing of complex systems, with a strong focus on German language fluency.The ideal candidate will have experience in test management for complex systems and interfaces, with a proven track record of delivering high-quality results.Key ResponsibilitiesTest Concept Development: Further...

  • Księgowa / Księgowy (Accountant)

    1 miesiąc temu

    Lublin, lubelskie, lubelskie, Polska BSI Group Polska Sp. z o.o. Pełny etat

    Księgowa / Księgowy (Accountant)Miejsce pracy: LublinYour responsibilitiesManage the end-to-end invoicing process for clients in Poland and East Cluster.Active participation in the collection process.Preparing VAT Declaration- Standard Audit File for Tax (VAT_ JPK).Invoicing using new governmental platform – KSeF ( National e-Invoice System).Ensure the...

  • Regulatory Operations Associate

    4 dni temu

    Lublin, Polska Pharmiweb Pełny etat

    Regulatory Operations Associate - Poland - Home or office based but preference is for the person to work from our Warsaw office ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the...

  • Senior Backup Infrastructure Manager

    3 tygodni temu

    Lublin, Polska DCV Technologies Pełny etat

    Job Title: Senior Backup Infrastructure ManagerDCV Technologies is seeking an experienced Senior Backup Infrastructure Manager to join their team. The ideal candidate will have a strong background in data protection and recovery, with a focus on designing, implementing, and administering backup infrastructure.Key Responsibilities:Design and implement backup...

  • Test Automation Manager with German

    2 tygodni temu

    Lublin, Polska Trimetis Services Pełny etat

    Our client, the banking division of one of the major German car manufacturers, implements measures as part of the steering and regulatory requirements of the financial regulator.The underlying software is an off the shelf finance software, cloud-based and runs in the hardened Amazon AWS rooms.The software is delivered as a release 4 times a year per quarter....

  • SCCM Infrastructure Specialist

    3 tygodni temu

    Lublin, Polska DCV Technologies Pełny etat

    SCCM AdministratorWe are seeking an experienced SCCM Administrator to join our team at DCV Technologies. This is an exciting opportunity to be part of a forward-thinking environment where you can help optimize IT infrastructure for a major industry leader.Key Responsibilities:Daily support of the SCCM environment, including resolving Incident Tickets,...

  • Sr Medical Editor

    1 miesiąc temu

    Lublin, Polska Pharmiweb Pełny etat

    Description Senior Medical Editor Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center...

  • SCCM Administrator

    4 tygodni temu

    City, Lublin, Polska DCV Technologies Pełny etat

    SCCM Administrator Job DescriptionDCV Technologies is seeking an experienced SCCM Administrator to join our team. As a key member of our IT infrastructure team, you will be responsible for the daily support of our SCCM environment, including resolving incident tickets, service requests, and change tickets as required.Key Responsibilities:Provide daily...

  • SCCM Senior Administrator

    2 tygodni temu

    City, Lublin, Polska DCV Technologies Pełny etat

    At DCV Technologies, we are seeking an experienced SCCM Administrator to lead our IT infrastructure optimization efforts. This role presents an exciting opportunity to be part of a forward-thinking environment where you can help shape the future of the automotive industry through cutting-edge IT solutions.Key Responsibilities:Daily support of the SCCM...