Senior Product Expert- Regulatory, Warsaw

3 tygodni temu


Warszawa, Mazovia, Polska TN Poland Pełny etat
Senior Product Expert- Regulatory, Warsaw

Job Summary: This is an exciting opportunity to join Haleon as a Senior Product Expert- Regulatory. As a key member of the team, you will be responsible for all aspects of the Regulatory technology ecosystem, including business and technical analysis, backlog management, agile delivery model and methodology, operational performance, enhancements, replacement, and future capability roadmaps.

About the Role

The Senior Product Expert- Regulatory is accountable for all aspects of the Regulatory technology ecosystem relating to Regulatory vault, Publishing, including but not limited to business and technical analysis, backlog management, agile delivery model and methodology, operational performance, enhancements, replacement, and future capability roadmaps.

Recognized as the Regulatory systems product expert and trusted advisor; removing business and technical blockers, working collaboratively and adaptively to constantly meet the needs of their customers and deliver value to Haleon.

Key Responsibilities
  1. Technology Strategy & Enablement: Develop and align partners on a vision and roadmap for the relevant regulatory areas including business analysis, technology evaluation and capabilities to support and accelerate R&D scientific and research goals and compliant regulatory activities in line with external health authorities at a global scale.
  2. Demand Management: Collaborate and influence senior business leaders to handle and prioritize the product backlog with a focus on the highest business value.
  3. Product/Project Delivery: Leadership, execution, and maintenance for existing Regulatory platforms and with an eye towards emerging innovative technologies.
  4. Quality, Risk & Compliance: Ensuring all regulatory tech products supporting the business are aligned with internal security, risk management policies and practices, continuity plans, external regulatory and statutory requirements e.g. GxP and that Tech continuity plans are in place for all critical products and ensuring the documentation is in place as per ITMS guidelines.
  5. Service Management: Responsible for ensuring the right services levels are in place and ensure alignment to those SLAs. Directly manage any Level 3 Support issues and escalations.
  6. Adoption Strategy & Change Management: In the role of change agent, support both the product teams and the business in agile approaches to solution development and adoption, building excitement, momentum, visible success stories and clear value-based versions of vision as roadmap plans come to life.
Qualifications and Skills
  1. Expert knowledge and experience of products in Regulatory space.
  2. Experience with Veeva Regulatory Vault, DXC Publishing or equivalent case RIM platforms.
  3. Proven understanding of the Regulatory, ICH GCP and GxP regarding systems validation and documentation.
  4. Experience of working within Agile delivery methodology with an understanding of the system development lifecycle.
Preferred Skills
  1. Communication Skills: Ability to adjust communication style to suit different levels of business and technical hierarchy, ensuring clarity and understanding across various stakeholders.
  2. Collaboration: Proficiency in working across product pillars or areas of the CDTO, R&D team, and other departments to achieve common goals.
  3. Technical and Team Leadership: Expertise in managing virtual teams, providing direction, and fostering a collaborative team environment.
  4. Adaptability: Capacity to adapt to internal or external changes in technology and the organizational landscape, maintaining effectiveness and efficiency.
  5. Emotional Intelligence: Ability to navigate through the social dynamics of diverse teams and stakeholders, understanding and managing emotions to build strong relationships.
  6. Presentation Skills: Competence in delivering immersive presentations that clearly articulate the value benefits of technology designs and convey complex ideas in an understandable manner.
  7. Problem-Solving: Strong analytical skills to evaluate technical and business challenges, deriving solutions through critical and creative thinking.
Opportunities for Growth

We offer a range of opportunities for growth and development, including career progression, training and education programs, and access to the latest technology and tools.

Our benefits package includes:

  1. Career at one of the leading global healthcare companies.
  2. Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement).
  3. Extensive support of work life balance (flexible working solutions including working from home possibilities, health & wellbeing activities).
  4. Family benefits (extra parental leave, caregiver's policy).
  5. Life insurance and pension plan.
  6. Open and inclusive environment which is supportive and welcoming of all diversity strands (gender, race, ethnicity, sexuality, disability, or any other characteristic).
  7. Private medical package with additional preventive healthcare services for employees and their eligible counterparts.
  8. Sports card (Multisport).
  9. Personalized learning approach.
  10. Supportive community and integration events.
  11. Modern office with creative rooms.
  12. Free car and bike parking.
Why Join Us?

The future of everyday health is changing, and we're the people changing it. In front of us is an incredible opportunity to go beyond what any of us have done before and make everyday health more achievable, more inclusive and more sustainable for more and more people.

Join us, as we build one of the world's leading consumer healthcare companies, innovate our category-leading brands, better understand people's everyday health needs, tackle the biggest barriers that stand in their way, change individual and societal behavior, and work with colleagues who share your restless energy.



  • Warszawa, Mazovia, Polska Goldman Sachs Bank AG Pełny etat

    We're looking for a talented individual to join our Financial Crime Compliance team as a Vice President. As a key member of our KYC Product Management team, you'll be responsible for developing and leading the product strategy for KYC solutions.Your strong understanding of KYC/AML landscapes, regulatory frameworks, and product innovation will enable you to...

  • Regulatory Affairs Senior

    2 tygodni temu


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

    For our Client, one of the biggest Pharmaceutical Companies worldwide, we are looking for a Regulatory Affairs Senior / Specialist in Submission Publishing who will be responsible for executing the electronic publishing of complex regulatory submissions for national, regional and global regulatory agencies and operating companies in both eCTD and non-eCTD...


  • Warszawa, Mazovia, Polska Randstad Pełny etat

    For our esteemed Client, one of the world's largest pharmaceutical companies, we seek a highly skilled Regulatory Compliance Expert to oversee the operational delivery of regulatory documents for product registration and compliance. This individual will lead the team and coordinate plans for packages of documents sent.Key ResponsibilitiesManage regulatory...


  • Warszawa, Mazovia, Polska Randstad Pełny etat

    Randstad is seeking a talented Compliance and Regulatory Expert to work on a critical project. The successful candidate will be responsible for managing the operational submission process and delivering regulatory submissions to support product development, registration, and compliance.About the Role:This is an exciting opportunity to work with a large...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    Step into a pivotal role as Manager, Regulatory Affairs and contribute to the global development and lifecycle management of groundbreaking pharmaceutical products. As a key member of team, you will lead the development and execution of global CMC regulatory strategies, ensure compliance with regulatory requirements, and represent Global CMC Regulatory...


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

    We are seeking a highly skilled Regulatory Affairs Publishing Specialist to join our team in Warsaw, Poland.The ideal candidate will have experience in navigating complex regulatory submissions and publishing requirements, as well as excellent communication skills.Job Description:Executing the electronic publishing of moderate to complex regulatory...


  • Warszawa, Mazovia, Polska Randstad Pełny etat

    Job SummaryA highly skilled Regulatory CMC professional is sought to drive global regulatory strategies for innovative pharmaceutical products. This individual will lead the preparation of strategic regulatory plans, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development.Key...


  • Warszawa, Mazovia, Polska TN Poland Pełny etat

    Job OverviewThe Senior Regulatory Specialist, Country Labelling is a key role within TN Poland, responsible for ensuring the effective coordination, communication, and maintenance of regional/country labelling documents. This position requires strong leadership skills to provide support to global and local GRA team members.Key Responsibilities:Authoring and...


  • Warszawa, Mazovia, Polska Randstad Pełny etat

    Job SummaryA highly skilled Regulatory CMC Manager is sought to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. This individual will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development.Key...


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

    ManpowerGroup Sp. z o.o., a global leader in workforce solutions, is seeking an experienced Regulatory Affairs Submission Expert to join our team.We are recruiting for a mid-level and senior position that requires collaboration with colleagues to ensure compliance with regulatory agency regulations and interpretation.Main Responsibilities:Create and manage...


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

    ManpowerGroup Sp. z o.o., a global leader in the staffing industry, is seeking a Regulatory Affairs Publishing Expert to join our team.The ideal candidate will be responsible for executing the electronic publishing of complex regulatory submissions for national, regional and global regulatory agencies and operating companies in both eCTD and non-eCTD...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    We are looking for an exceptional Regulatory Compliance Expert to join our team and drive strategic initiatives related to Clinical Trials and Product Development.About the RoleLead high-performing teams and drive Clinical Research Strategies that meet regulatory requirements and improve patient outcomes.Solid understanding of biology, chemistry, and...


  • Warszawa, Mazovia, Polska Standard Chartered Pełny etat

    About the RoleThe CIB Strategic Regulatory Initiatives Team is a key component within the Corporate & Investment Banking (CIB) business, operating under the COO office.This team provides CIB with capabilities to drive regulatory and risk programmes and initiatives across CIB businesses, working in an agile operating model with each segment and product area....


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    Regulatory CMC ManagerWe are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products.About the RoleIn this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    We are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. In this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development. This...


  • Warszawa, Mazovia, Polska Pearson Pełny etat

    About the Team:Our team at Pearson is dedicated to delivering high-quality services to our customers.We are a collaborative and supportive team that values diversity, equity, and inclusion.The Role:We are seeking a skilled Payroll Compliance Senior Lead Analyst to join our team at Pearson.As a key member of our payroll team, you will be responsible for...


  • Warszawa, Mazovia, Polska Standard Chartered Pełny etat

    The CIB Strategic Regulatory Initiatives Team is responsible for driving regulatory and risk programmes across CIB businesses.As a Regulatory Change Management Expert, you will lead the delivery of large-scale regulatory change programmes with responsibility for establishing and coordinating underlying workstreams.You will manage resource requirements,...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    For our Client, one of the largest Pharmaceutical Companies worldwide, we are looking for a Senior Manager, Regulatory Affairs Regional Strategy Implementation. This position resides within Global Regulatory Affairs and provides regional regulatory strategic implementation support for products in one or more therapeutic areas. The successful candidate will...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    Job Overview:Our client, a leading pharmaceutical company, is seeking a Regulatory Affairs Senior/Specialist in Submission Publishing. The successful candidate will be responsible for executing the electronic publishing of complex regulatory submissions for national, regional, and global regulatory agencies and operating companies in both eCTD and non-eCTD...


  • Warszawa, Mazovia, Polska Randstad Pełny etat

    Job OverviewRandstad is seeking a Pharmaceutical Product Development Manager to lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development. The successful candidate will be responsible for driving global regulatory strategies for innovative...