Huidige banen gerelateerd aan Regulatory Data Management Leader - Breda - Planet Pharma

  • Global Supply Management Leader

    7 dagen geleden

    Breda, Noord-Brabant, Nederland Hezuo Ltd Voltijd

    Job Summary:We are seeking an experienced leader to oversee our Customer Service team, ensuring exceptional performance and employee engagement.This is a unique opportunity to make a significant impact on our business, driving growth and improvement through effective supply chain management.

  • Regulatory Affairs Specialist

    6 dagen geleden

    Breda, Noord-Brabant, Nederland Scendea Voltijd

    Job DescriptionWe are seeking a highly motivated Regulatory Affairs Specialist to join our global team. The successful candidate will have a strong background in drug development and regulatory affairs, with experience in working with FDA, EMA, and/or MHRA submissions.The ideal candidate will have a high level of technical knowledge in product development...

  • Regulatory Expert Consultant

    3 dagen geleden

    Breda, Noord-Brabant, Nederland Scendea Voltijd

    Job OverviewAs a Principal Consultant (CMC) at Scendea, you will play a key role in the development and mentoring of staff while providing high-quality regulatory technical advice and product development strategies for clients. Your expertise in CMC development of human medicinal products will be invaluable to our global team.Responsibilities:Provide...

  • Senior Regulatory Consultant

    7 dagen geleden

    Breda, Noord-Brabant, Nederland Scendea Voltijd

    Job DescriptionWe are seeking a highly motivated Senior Regulatory Consultant to join our global team. This is a hybrid position, affiliated to our Netherlands office, with a requirement to work in the office a minimum of one day per month.This is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy. You will have the...

  • CMC Development Expert

    6 dagen geleden

    Breda, Noord-Brabant, Nederland Scendea Voltijd

    Company Overview: Scendea is an international product development and regulatory consulting group delivering market-leading scientific expertise & regulatory solutions, to advance healthcare innovation worldwide. Our team of experts provides strategic and operational support to clients, with a strong commitment to problem-solving and redefining customer...

  • Quality Management Specialist

    4 weken geleden

    Breda, Noord-Brabant, Nederland Panda International Voltijd

    Job Title: Quality Management Records Owner (Change Controls, Deviations, CAPAs) In this role, you will be the owner of engineering change control / deviation/ CAPA records, assuring the completeness, accuracy and effectiveness of these records. You will ensure that all quality records are maintained in compliance with regulations and company quality...

  • Supply Chain Specialist

    3 dagen geleden

    Breda, Noord-Brabant, Nederland ThermaSolutions Voltijd

    We are seeking a highly organized and detail-oriented Supply Chain Specialist to join our team at ThermaSolutions. As a key member of our logistics team, you will be responsible for managing international orders, coordinating shipments, and ensuring timely delivery of medical products.Job Description:· Develop and implement efficient logistics processes to...

  • Quality Management Records Owner

    5 dagen geleden

    Breda, Noord-Brabant, Nederland Real Staffing Voltijd

    Job Vacancy: Quality Management Records Owner (Change Controls, Deviations, CAPAs) Location: BredaRole Overview: As the owner of engineering change control, deviation, and CAPA records, you will ensure the completeness, accuracy, and effectiveness of these records. You will maintain all quality records in compliance with relevant regulations and company...

  • Quality Management Records Owner

    4 weken geleden

    Breda, Noord-Brabant, Nederland Real Staffing Voltijd

    Job Vacancy: Quality Management Records Owner (Change Controls, Deviations, CAPAs) Location: Breda Role Overview: As the owner of engineering change control, deviation, and CAPA records, you will ensure the completeness, accuracy, and effectiveness of these records. You will maintain all quality records in compliance with relevant regulations and company...

  • Quality Management Records Owner Position

    3 dagen geleden

    Breda, Noord-Brabant, Nederland Real Staffing Voltijd

    Job Overview:We are seeking a highly skilled Quality Management Records Owner to join our team at Real Staffing. As the owner of engineering change control, deviation, and CAPA records, you will ensure the completeness, accuracy, and effectiveness of these records.Main Responsibilities:Change Controls:Develop and implement change control processes.Ensure all...

  • Quality Management Records Owner

    1 week geleden

    Breda, Nederland Orion Voltijd

    Job description **Orion Group Life Sciences are looking for a Quality Management Records Owner for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 12-month contract, with possibility of extension. This is a hybrid position, where you have to be 2-3 days onsite.** **Job Purpose** In this role, you will be the owner of...

  • Project Management Professional

    3 dagen geleden

    Breda, Noord-Brabant, Nederland KHS Benelux B.V. Voltijd

    IntroductionKHS Benelux B.V. is a leading manufacturer of beverage and liquid food systems, with a strong presence in the global market.We are seeking a highly skilled and experienced project manager to join our team, focusing on the implementation of SAP solutions for our clients.ResponsibilitiesThe successful candidate will be responsible for:Coordinating...

  • Graduate Management Traineeship Programme

    2 weken geleden

    Breda, Nederland AB InBev Voltijd

    Seniority Level: Entry level Launch Your Career with AB InBev: Graduate Management Trainee Program What is it? Our Graduate Management Trainee (GMT) programme is a - 1-year program starting in August 2025 - 3-4-month rotations within the program - As a junior talent, you will work on critical business projects both on the field and office-based analytical...

  • Data Team Lead

    2 weken geleden

    Breda, Noord-Brabant, Nederland AVEVA Select Benelux Voltijd

    Are you an experienced professional with a passion for partner success and a strong background in account management? We are looking for a Partner Success Practice Lead (PSPL) to join our team in the Benelux. In this key role, you will be responsible for managing relationships with our partners, including System Integrators, EPCs, and Schneider Electric. ...

  • CMC Development Expert

    5 dagen geleden

    Breda, Noord-Brabant, Nederland Scendea Voltijd

    Job DescriptionThis is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy. You will have the opportunity to play a key role in the development and mentoring of staff whilst providing high-quality regulatory technical advice and product development strategies for clients.You will provide strategic, technical and...

  • Data Analist

    2 weken geleden

    Breda, Nederland Brabant Water Voltijd

    Breda - 32 - 40 uur direct Wil jij de drijvende kracht zijn achter data-gedreven inzichten en besluitvorming? Ben je gepassioneerd over het ontrafelen van complexe gegevenspuzzels en het ontdekken van waardevolle inzichten in de wereld van drinkwater? Dan is deze uitdagende rol als Data Analist bij de sector productie iets voor jou! **Dit ga je...

  • Research Consultant Bij Building Leaders

    4 weken geleden

    Breda, Noord-Brabant, Nederland Building Heroes Voltijd

    Be a hero Als Research Consultant werk je nauw samen met de Managing Partner en/of Consultants en opdrachtgevers. Je speelt een sleutelrol in alle fasen van het searchproces, van marktonderzoek tot het vinden en benaderen van kandidaten. Jouw taken omvatten:Marktonderzoek en strategieontwikkeling: Je brengt de kandidatenmarkt in kaart en ontwikkelt een...

  • Research Consultant Bij Building Leaders

    4 weken geleden

    Breda, Nederland Building Heroes Voltijd

    Be a hero Als Research Consultant werk je nauw samen met de Managing Partner en/of Consultants en opdrachtgevers. Je speelt een sleutelrol in alle fasen van het searchproces, van marktonderzoek tot het vinden en benaderen van kandidaten. Jouw taken omvatten:Marktonderzoek en strategieontwikkeling: Je brengt de kandidatenmarkt in kaart en ontwikkelt een...

  • Business/data Analyst

    2 weken geleden

    Breda, Nederland BMW Financial Services Voltijd

    **Business/Data Analyst** **SOME SEE DATA, OTHERS SEE THE FUTURE.** **SHARE YOUR PASSION** Bij BMW Financial Services werk je aan de mobiliteit van de toekomst. Mobiliteit en de wensen die klanten daaraan stellen zijn voortdurend in beweging. Medewerkers met uitzonderlijke interpersoonlijke vaardigheden en een can-do-instelling zijn nodig om een geweldige...

  • Administratief Medewerker Lead Management

    1 week geleden

    Breda, Nederland SCANIA Voltijd

    Administratief medewerker lead management Breda Administratief/Secretarieel **Administratief Medewerker Lead Management** Als administratief medewerker lead management bij Scania Nederland in Breda, krijg je de kans om te werken in een innovatieve omgeving waar jouw inkoopvaardigheden direct bijdragen aan het succes van de Scania organisatie. Jouw...

Regulatory Data Management Leader

4 weken geleden

Breda, Nederland Planet Pharma Voltijd

Job Title: Director Regulatory Data Management


Roles & Responsibilities:

  • Deliver high-quality services and projects to customers for data management.
  • Lead a team specialized in submitting and reporting data related to Medicinal and pharmaceutical products, Organizations, and Substances.
  • Ensure the highest possible data quality and compliance with existing guidance, regulations, and data standards.
  • Collaborate closely with the Regulatory Affairs (RA) department of customers to support their business processes through correct data use and implementation.
  • Provide consultancy and support for process development, data cleansing, remediation activities, vendor selection, and system implementation.
  • Coordinate daily operations, project and resource planning for the Data Management group, and maintain excellent working relationships with customers.
  • Involve in the development of in-house solutions and function as a Subject Matter Expert when needed.
  • Support pre-sales and marketing initiatives related to regulatory data management.
  • Act as a line manager and coach to team members, helping them achieve goals and develop necessary skills.


Key Responsibilities & Tasks:

Coach Team Members

  • Coach on achieving goals and develop skills of individual team members.
  • Resolve conflicts.

Team Planning and Organization

  • Identify team goals, resource planning, and prioritize work activities.
  • Organize team roles and responsibilities.
  • Assist team with overflow duties.

Project and Services Delivery

  • Ensure high-quality projects and services are delivered to Data Management customers.
  • Consult with team members to ensure targets and deliverables are met.
  • Provide consultancy on data management aspects in business process development and implementation.

Vendor Selection and System Implementation

  • Evaluate and validate software supporting regulatory information management.
  • Lead the implementation of regulatory information management solutions and vendor selection.
  • Lead/support data migration and remediation tasks.

Quality Management System

  • Responsible for Data Management related processes and procedural documents.
  • Participate in the development, maintenance, and improvement of procedural documents and templates.

Track Regulatory Documents, Publications, and Other Related Materials

  • Proactively consult and check information sources for new, changed, and updated materials (e.g., new regulatory guidance or data standards).

Data Management

  • Monitor data quality and initiate mitigating and corrective activities.
  • Ensure compliance with guidelines and regulations.
  • Promote correct use of data.
  • Ensure timely and valid submission of electronic data submissions.

Solution Development Support

  • Support technical solutions for regulatory data management as an SME.
  • Implement tech-enabled services to increase efficiency, quality, and consistency.

Formal Education:

  • Higher professional education (or equivalent combination of education and experience), preferably in Life Sciences.

Experience:

  • Expert knowledge of Regulatory Affairs, particularly regulatory information management, with at least 10+ years of professional experience.
  • Knowledge and experience in the drug development process, regulatory filing guidelines, and electronic submissions.
  • Experience with data management tools and platforms relevant to the life sciences industry.
  • Experience with software development is a plus.


Qualifications: General Soft Skills

  • Affinity with Information Technology and automation.
  • Strong leadership abilities.
  • Good organizational skills, including efficiency and collaboration in a team environment.
  • Proficiency with computer skills, including MS Office and Adobe Acrobat.
  • Ability to manage and deliver through others in a matrix environment.
  • Ability to work in a demanding environment with a strong focus on quality and timelines.
  • Passion for data quality and commitment to continuous improvement.
  • Eager to learn various technical tools.
  • High analytical skills.
  • Flexibility and adaptability to emerging situations.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Proficiency in English (spoken and written).
  • Quality-focused with a systematic and consistent approach.
  • Ability to work concurrently on multiple projects with varying features