Regulatory Information Specialist

il y a 2 semaines

BoulogneBillancourt, France Ipsen Innovation (SAS) Temps plein

The Regulatory Information Specialist plays a crucial role in managing regulatory data, ensuring compliance with EMA requirements, and optimizing regulatory information systems. This position primarily focuses on managing regulatory structured data, administering EMA-related systems, and enhancing SharePoint functionalities within the Global Regulatory Affairs (GRA) framework.

**WHAT -**Main Responsibilities & Technical Competencies**

**Regulatory Structured Data management**
- Support IDMP readiness activities, with a focus on regulatory data, to ensure alignment with EMA standards.
- Perform data remediation to enrich the RIM database and ensure consistency with IDMP standards.
- Fulfill EMA data-related requests (e.g., QC of PMS data, manufacturer enrichment in PMS).
- Define and implement IDMP data flow processes in collaboration with Subject Matter Experts (SMEs).
- Ensure compliance and create value through effective management of non-transactional regulatory data.
- Support xEVMPD submissions in close collaboration with contributing functions (including data owners).
- Perform quality control on data imports from xEVMPD to PMS.
- Align regulatory data management processes with Veeva Vault standards.
- Contribute to the optimization of regulatory data tracking and reporting.

**EMA Systems Administration**
- Handle EMA account access requests (SPOR, PLM, IRIS, CTIS,OMS ).
- Maintain documentation related to EMA accounts and associated trainings.
- Coordinate Ipsen’s compliance with EMA database obligations
- Communicate to Regulatory Community relevant information and potential actions to be done.

**Regulatory SharePoint Management**
- Work with GRA teams to identify needs and improve SharePoint sites.
- Evaluate technical feasibility, implement updates, and add automation where helpful.
- Ensure SharePoint sites work well and are easy to use.
- Handle requests for new site creation, content migration, and archival of outdated information.
- Monitor SharePoint usage and performance, and proactively address any issues.
- Provide user support and training to improve adoption and correct use of SharePoint features.
- Organize content using clear site structures to make information easier to find.
- Manage user access, permissions, and groups to ensure data security.
- Perform additional tasks related to access management, permissions, and other related needs as required.

**HOW - Knowledge & Experience**

Knowledge & Experience (essential):

- 3 years of experience in database management
- Experience managing IDMP or XEVMPD.
- Proven ability to lead cross-functional projects.
- Strong organizational, interpersonal, and negotiation skills.
- Excellent written and verbal communication skills.
- Good understanding of Regulatory Information Systems.
- In-depth knowledge of RIM data models and EMA regulatory systems.

Knowledge & Experience (preferred):

- Experience in the pharmaceutical industry
- Experience in Regulatory Affairs
- Experience with Master Data Management.

Education / Certifications (essential):

- Advanced degree in Life Sciences (Life Science Engineering or equivalent)

Language(s) (essential):

- Professional proficiency in English.

Language(s) (preferred):

- Fluent in French

  • Regulatory Affairs Specialist

    il y a 4 jours

    Boulogne-Billancourt, France Excelya Temps plein

    **About the Job** Join Excelya as a **Regulatory Officer** **& Promotional Information**, where **Audacity, Care, and Energy** define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a...

  • Senior Manager, Global Regulatory Affairs

    il y a 4 jours

    Boulogne-Billancourt, France Ipsen Innovation (SAS) Temps plein

    **SUMMARY OF THE ROLE** To be accountable for the strategy, tactics and implementation of all regulatory aspects of the assigned programs and all of its components for assigned region or worldwide. - To provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned products/projects. - Act as the interface between the...

  • International Benefits Specialist, Nuclear

    il y a 6 jours

    Boulogne-Billancourt, France GE Power Portfolio Temps plein

    **Job Description Summary**: Contexte EDF est en train d’acquérir les activités nucléaires de GE Steam Power, sous réserve des conditions nécessaires, notamment des approbations réglementaires. Ce projet d’acquisition créera une opportunité de transformation. Dans un contexte de changement à grande échelle, la rémunération et les avantages...

  • Etmf Specialist

    il y a 1 semaine

    Boulogne-Billancourt, France Excelya Temps plein

    Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team. You will play a critical part in driving innovation and...

  • Etmf Specialist

    il y a 2 semaines

    Boulogne-Billancourt, France Excelya Temps plein

    RemoteOperations, Clinical Ops & eTMFFull time Boulogne-Billancourt, Île-de-France, France OVERVIEW Description Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting...

  • HRis Specialist

    il y a 1 semaine

    Boulogne-Billancourt, France IPSEN Temps plein

    **Title**: HRIS Specialist **Company**: Ipsen Pharma (SAS) **Summary / purpose of the position** The scope is global, covering 5800 users in 35 countries. **Main responsibilities / job expectations** - **HRIS Support management** - Provide support to users by analyzing, categorizing and answering their requests - Escalate the tickets when needed...

  • Svp, Head of Global Patient Safety

    il y a 2 semaines

    Boulogne-Billancourt, France IPSEN Temps plein

    **Title**: SVP, Head of Global Patient Safety **Company**: Ipsen Pharma (SAS) - The Senior Vice President, Global Patient Safety is accountable to define the overall Patient Safety strategy for Ipsen across the portfolio (Oncology, Neurosciences, Rare Diseases) from Discovery to development and post marketing approvals’ maintenance, in order to meet...

  • Marketing Specialist

    il y a 7 heures

    Boulogne-Billancourt, France LINK Mobility Temps plein

    OverviewWe’re looking for a Marketing Specialist to help shape the future of business messaging at LINK Mobility - Europe’s leading mobile messaging and CPaaS provider. At LINK, we power communication that keeps everyday life moving. From flight check-ins and delivery alerts to SMS authentication, WhatsApp support messages, and mobile coupons - chances...

  • Spécialiste Sûreté à l'international F/H

    il y a 4 semaines

    Boulogne-Billancourt, France MBDA Temps plein

    Le poste de Spécialiste Sûreté à l'international F/H Dans le cadre de l'expansion des activités de MBDA, la Direction Sûreté Group renforce ses équipes afin de garantir la sûreté des salariés de l'entreprise affectés ou se déplaçant à l'international. Rattaché au Responsable Sûreté à l'International, le Spécialiste Sûreté assure la mise...

  • Spécialiste Projets Parcours de Soins

    il y a 6 heures

    Boulogne-Billancourt, France Allergan Aesthetics Temps plein

    Overview AbbVie France recrute un.e Spécialiste Projets Parcours de Soins rattaché.e à la Responsable National Parcours de Soins. Le poste s’inscrit dans une collaboration avec les équipes In Field et la stratégie de l’aire thérapeutique concernée, en alignement avec les orientations d’AbbVie France. La mission d’AbbVie est de découvrir et de...