Project Manager Regulatory Ecosystems

il y a 21 heures

Les Ulis, France IPSEN Temps plein

**Title**:
Project Manager Regulatory Ecosystems

**Company**:
Ipsen Innovation (SAS)

In close collaboration with the Regulatory Systems Owner and Regulatory System Support and within the framework to leverage and improve the Regulatory Ecosystems
- Manage systems trainings
- Participation in tool’s evolution
- Oversight manager provider
- Manager systems improvement project

**Activities List**

**Main Responsibilities**

**Main Tasks**
- ** Manage trainings**
- Get full knowledge of the systems configuration and processes
- Update existing trainings
- Manage trainings evolution with the service provider
- Develop advanced specialized trainings
- ** Participation in tool’s evolution**

Participate to the regulatory ecosystems change management in support to the System Owner
- Diagnose the systems and propose improvements ways
- Quick win, supportive material
- Interviewing key stakeholders to harmonize processes
- Ensure the launch and follow-up of the regulatory impact assessment and validation by “change control board” and validate the implementation of the evolution
- Drive / Execute informal and formal tests
- Develop and/or Execute Business qualification testing scripts
- Support system validation activities ensuring high quality user acceptance/ performance qualification testing scripts and providing review capability for operation qualification scripts
- ** Oversight Service Provider**

In close collaboration with the systems owner:

- Oversight day to day activities of the service provider
- Answer level 2 questions from users
- Follow up activities with routines meeting.
- ** Project Management**
- Launch and lead planification
- Launch and lead Systems Super User Organization
- Propose and participate in systems improvement project

**Experience / Qualifications**

**Ideal**:

- At least 4 years professional experience, including 1-year experience in Corporate Regulatory Affairs
- Experience in learning & training Management.
- Experience within systems development & validation.
- French & English language fluent.
- **Minimum**:

- Degree in life science discipline including background on medicinal products (pharmacist, life science engineer, software & physiology engineering) or equivalent professional experience
- At least 2 years professional experience, including 1-year experience in Regulatory Affairs or IT
- Tact and helpful attitude
- Good organizational skills, interpersonal and negotiation skills
- Good written and oral communication skills
- Professional English, written and oral, if not mother tongue

  • Regulatory Compliance Manager

    il y a 5 jours

    Les Ulis, France CA Mining Temps plein

    Job Description Our client, a leading global engineering and technology player, is seeking a Regulatory Compliance Manager to oversee their onshore and offshore compliance. The incumbent will contribute to the Regulatory Compliance team. With 60 years of experience in energy project design, the division comprises 600 professionals representing all...

  • Senior Manager, Global Regulatory Affairs

    il y a 7 jours

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    Job title**:Senior Manager, Global Regulatory Affairs TA** Department: Research & Development, Global Regulatory Affairs (GRA) Line Manager (name, job title): VP/Sr Dir/Dir, Global Regulatory Affairs, Therapeutic Area Location of the role: France, (Les Ulis or Boulogne-Billancourt) **Summary / purpose of the position** - To be accountable for the...

  • Global Regulatory Affairs Consultant

    il y a 5 jours

    Les Ulis, France Real Temps plein

    Join to apply for the Global Regulatory Affairs Consultant role at RealJoin to apply for the Global Regulatory Affairs Consultant role at RealThis range is provided by Real. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Our client, a leader in the industry, is looking for a Global Regulatory Affairs...

  • Expert, Cmc Regulatory

    il y a 7 jours

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    Job Title: Expert CMC Regulatory Division / Function: Global Regulatory Affairs - CMC Regulatory Manager (Name, Job Title): Senior Manager, Director, or Senior Director CMC Regulatory Location: Ipsen location in France / Ireland / UK **Summary / purpose of the position** - Prepare the CMC regulatory strategy for assigned projects under the strategic...

  • Alternance - Global Regulatory Affairs Operations

    il y a 2 jours

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    As a Regulatory Operation internship, you will play a role in supporting Regulatory operation projects aimed at enhancing regulatory activities by using Regulatory information management system capabilities. You will work closely with our Regulatory, Regulatory operation, System& IT team to contribute to the development and implementation of strategies to...

  • Alternance - Global Regulatory Affairs

    il y a 1 semaine

    Les Ulis, France IPSEN Temps plein

    **Title**: Alternance - Global Regulatory Affairs, Neurosciences M/F **Company**: Ipsen Innovation (SAS) IpsenTraineeSquad Ipsen is pleased to open a **12-month apprenticeship **(alternance) in the Global Regulatory Affairs, Neuroscience team! We are looking for a motivated **Regulatory Affairs student** **to work in our R&D office in **Les Ulis**,...

  • Alternance - Regulatory Affairs Rare Diseases (M/F)

    il y a 1 semaine

    Les Ulis, France IPSEN Temps plein

    **Title**: Alternance - Regulatory Affairs Rare Diseases M/F **Company**: Ipsen Innovation (SAS) IpsenTraineeSquad Ipsen is pleased to open a **12-month apprenticeship **(alternance) in the Global Regulatory Affairs, Rare Disease team! We are looking for a motivated **Regulatory Affairs student** **to work in our R&D office in **Les Ulis**, France. - 12...

  • Alternance - Regulatory Affairs Cmc F/m - From

    il y a 2 jours

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **Regulatory coordination**: - Participate to the CMC regulatory strategy liaising with cross functional teams - Check current regulations to ensure strategy is developed in alignment - Participate to build, review and maintain CMC regulatory documentation for ongoing clinical programs (IMPD/IND) - Participate in the authoring and reviewing phase of...

  • Regulatory Compliance Lead – Maritime

    il y a 5 jours

    Les Ulis, France CA Mining Temps plein

    A leading global engineering firm is seeking a Regulatory Compliance Manager to oversee compliance activities across onshore and offshore projects. The successful candidate will facilitate engagement with Class Societies, manage contract close-outs, and ensure timely issuance of mandatory documents. Candidates should possess an engineering degree and have at...

  • Project Manager

    il y a 5 jours

    Les Ulis, France Medium Temps plein

    We are seeking a dynamic and experienced Project Manager to join our consulting firm, which specializes in providing innovation services to technology companies and government agencies. The successful candidate will be responsible for leading and managing projects that drive innovation, from strategy development to execution. This role requires a strong...