Director, Regulatory Systems
il y a 1 mois
**Position**
Job Title**:Director, Regulatory Systems Lead**
Division / Function: Global Regulatory Affairs - Regulatory Operations
Manager (Name, Job Title): Head of RegOps, GRA
Location: Boulogne / Les Ulis - France
**Summary / purpose of the position**
Position Overview:
**Main responsibilities / job expectations**
**Direct management of the system team**
In this role, you will lead and mentor a team of regulatory operations professionals, fostering a collaborative and inclusive work environment. You will provide direction and guidance to ensure your team is well-equipped to meet regulatory compliance and operational goals. This includes overseeing the direct management of team members. You will be responsible for their professional development, performance management, and fostering an environment that encourages innovation, continuous learning, and cross-functional collaboration. Your leadership will be pivotal in aligning team efforts with the broader organizational objectives and driving efficiency.
**Lead RIM and System enhancements**:
**Influence and High-Level Interaction**:
Effectively influence and engage with high-level stakeholders to drive regulatory initiatives and ensure alignment with organizational objectives. Be an active participant in the Submission Excellence Project, leveraging your expertise to enhance submission processes and outcomes. Utilize strong interpersonal and communication skills to advocate for regulatory operations needs and ensure buy-in from senior leadership.
**Agility and Continuous Improvement**:
Promote agility in regulatory operations by implementing innovative solutions and best practices. Drive continuous improvement initiatives to enhance operational efficiency and responsiveness. Monitor industry trends and regulatory changes to proactively adjust processes and systems. Define the strategy for systems implementation and evolution.
**Reporting and Compliance Communication**:
Develop robust reporting mechanisms to communicate compliance status, risks, and system performance to senior management and stakeholders. Ensure regular updates and detailed reports are provided to facilitate decision-making and maintain transparency in GRA. Utilize data analytics and reporting tools to track compliance metrics and generate actionable insights.
**Develop and enforce data standards, policies, and procedures.**
Conduct regular audits and assessments to ensure regulatory data compliance with global health Promote RA systems capabilities for improving transversal processes (e.g., change control management, labeling implementation follow-up, pharmacovigilance needs). Set up and/or update available regulatory affairs SOPs, instructions, and guides to integrate the use of RA systems and ensure the best return on investments.
**Regulatory Operations Leadership Team**:
Join the Regulatory Operations leadership team, contributing to the strategic direction and decision-making processes of the department. Collaborate with other leaders to align on priorities, share best practices, and drive the overall success of regulatory operations initiatives. Provide insights and recommendations based on regulatory systems expertise to support the department's goals and objectives.
**Data Integration**:
Manage the integration of regulatory data and associated processes when Ipsen acquires a new company.
Ensure seamless transition and integration of acquired regulatory information into existing systems.
Technical Strategy and Oversight:
**Project Management**:
Manage multiple projects linked to system and data integration simultaneously, ensuring timely and successful completion. Develop project plans, timelines, and budgets. Define budget aspects related to system implementation and maintenance in collaboration with IT. Communicate project status, risks, and issues to stakeholders. Act as the contact person with software providers for project implementation, system upgrades, and support.
**EHS responsibilities**:
- Respect and enforce applicable EHS regulations and procedures.
- Promote EHS dynamics within teams for the proper functioning of the EHS management system
- Participate in the prevention of accidents at work by carrying out the Managerial Safety Visits (VMS) of its employees
- Ensure the completion of mandatory EHS training by his collaborator
**Knowledge, abilities & experience**
Education / Certifications:
- Advanced degree in Life Sciences, Information Technology, Regulatory Affairs, or related field;
**Experience**:
- Minimum of 10-15 years of experience in regulatory operations within the pharmaceutical industry.
- Proficiency in Veeva Vault RIM Suite, eCTD management systems, and other regulatory systems.
- Strong understanding of global regulatory requirements and compliance standards.
- Proven track record of enhancing RIM capabilities, managing other regulatory systems, and driving process improvements.
- Experience in managing regulatory data integratio
-
Regulatory Systems Operations Director
il y a 2 semaines
Les Ulis, Île-de-France Ipsen Pharma Temps pleinJob OverviewWe are seeking a highly motivated and experienced Director, Regulatory Systems Operations to join our team at Ipsen Pharma. This role will be responsible for enhancing our Regulatory Information Management (RIM) capabilities, ensuring compliance of regulatory data, and driving agility in our regulatory processes using Veeva systems.
-
Director, Regulatory Systems
il y a 3 semaines
Les Ulis, Essonne, France Ipsen Pharma Temps pleinTitle: Director, Regulatory Systems Company: Ipsen Innovation (SAS) Job Description: Position Job Title: Director, Regulatory Systems Lead Division / Function: Global Regulatory Affairs - Regulatory Operations Manager (Name, Job Title): Head of RegOps, GRA Location: Boulogne / Les Ulis - France Summary / purpose of the position Position...
-
Director, Regulatory Systems
il y a 3 semaines
Les Ulis, Essonne, France Ipsen Pharma Temps pleinTitle: Director, Regulatory Systems Company: Ipsen Innovation (SAS) Job Description: Position Job Title: Director, Regulatory Systems Lead Division / Function: Global Regulatory Affairs - Regulatory Operations Manager (Name, Job Title): Head of RegOps, GRA Location: Boulogne / Les Ulis - France Summary / purpose of the position Position Overview:...
-
Expert, Cmc Regulatory
Il y a 4 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinJob 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...
-
Director Cmc Regulatory Processes and Systems
il y a 3 semaines
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** **Provide strategic and technical CMC regulatory input to improve processes and facilitate interfaces with stakeholders for the purpose of maximizing CMC regulatory business from early development to life cycle management, facilitating submissions, approvals from CMC perspective of new assets and variations in a timely...
-
Regulatory Systems Lead
il y a 2 semaines
Les Ulis, Île-de-France Ipsen Pharma Temps pleinEstimate Salary: $120,000 - $180,000 per annumCompany OverviewIpsen Pharma is a leading pharmaceutical company dedicated to improving patient outcomes through innovative therapies. Our team is passionate about delivering high-quality solutions that meet the evolving needs of our customers.About the RoleWe are seeking an experienced Regulatory Systems Lead to...
-
Senior Director Cmc Regulatory Strategy
il y a 3 semaines
Les Ulis, France Ipsen Innovation (SAS) Temps pleinJob Title**: Sr Director CMC Regulatory Strategy - Small molecules** Division / Function: Global Regulatory Affairs (GRA) Manager (Name, Job Title): Head of CMC Regulatory Strategy Location: Balard/ Paddington **Summary / purpose of the position** - Leads the team to deliver high quality CMC-Regulatory files, ensuring alignment of regulatory strategy...
-
Senior Director Regulatory Cmc Strategy
il y a 3 semaines
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** - Leads the team to deliver high quality CMC-Regulatory files, ensuring alignment of regulatory strategy with all stakeholders. - Takes accountability/decision making for all Global CMC-Regulatory files in the biologic cluster. - Accountable for early communication and validation from worldwide health authorities for any...
-
Director Regulatory Affairs Rare Diseases
il y a 4 semaines
Les Ulis, 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...
-
Regulatory Manager
il y a 2 semaines
Les Ulis, France Ipsen Innovation (SAS) Temps pleinJob title: Regulatory Manager, Therapeutic Area Department: Global Regulatory Affairs (GRA) Line Manager (name, job title): Director/Sr Dir/VP Therapeutic Area Head, Global Regulatory Affairs **Purpose of the position** - ** Develop and implement regulatory strategies for the assigned projects and all its components for a major region or worldwide.**: -...
-
Alternance - Global Regulatory Affairs Operations
Il y a 7 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinAs 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...
-
Senior Manager, Cmc Technical Writing
Il y a 4 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinJob Title**:Senior Manager, CMC Technical writing Division / Function: Global Regulatory Affairs (GRA) Manager (Name, Job Title): Director/ Sr Director, CMC Regulatory Location: Balard/ Dublin/ Paddington **Summary / purpose of the position** The Senior manager, CMC-technical writing will have responsibility for the CMC (Chemistry Manufacturing and...
-
Operations Director
il y a 1 semaine
Les Ulis, France Hitachi Rail Systems France SAS Temps plein**Description** **Hitachi Rail's French entity is strengthening its teams and recruiting an Operations Director M/F on a permanent contract, for its Les Ulis site (91) - head office.** **About Us** **A career at Hitachi Rail will help create a legacy. With operations in every corner of the world, our work goes to the cutting-edge of digital transformation...
-
Biometric Systems Manager F/m
il y a 1 semaine
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** The Biometric Systems Manager drives successful implementation and use of clinical data management systems (CDMS) and Statistical Computer environment (SCE) in relation to planning, Implementation, Adoption & Maintenance. The Biometric Systems Manager delivers projects working multidisciplinary teams such as data...
-
Security Architecture
il y a 2 semaines
Les Ulis, France Colt Technology Services Temps pleinColt provides network, voice, and data centre services to thousands of businesses around the world, allowing them to focus on delivering their business goals instead of the underlying infrastructure.Why we need this role:#LI-DNI As the Director of Security Architecture and Engineering, you will play a pivotal role in shaping and executing our enterprise-wide...
-
Gra Compliance Manager
il y a 2 semaines
Les Ulis, France Ipsen Innovation (SAS) Temps plein**As Regulatory Compliance Manager within the GRA Excellence organization and under the Regulatory Compliance Senior Manager**: - Oversee all compliance aspects related to Global Regulatory Affairs activities in accordance with regulatory requirements and IPSEN standards. - Share compliance outcomes with the Global Regulatory Affairs community and relevant...
-
Clinical Scientist
Il y a 6 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** Providing leadership and management within Neuroscience Therapeutic Area Clinical Development to provide scientific and clinical development support for products (assets) within assigned therapy area. Support development and execution of medical & clinical strategy for assigned Ipsen assets(s). Conduct scientific...
-
Senior Clinical Monitoring Lead
Il y a 4 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinThe Senior Clinical Monitoring lead is fully accountable for all clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Phase I to III clinical studies in accordance with GCP guidelines and regulations. - He/she builds strong relationships with investigators and proactively acts as...
-
Talent & Culture Director
Il y a 4 mois
Issy-les-Moulineaux, France ORIENT EXPRESS Temps plein**Company Description** Within the Orient Express brand at Accor, the T&C Executive Director will be responsible and accountable for shaping and developing the Talent & Culture strategy. The T&C Director will have a key role in building the Social Relations strategy and agreements within Orient Express. **Why work for Accor?** We are far more than a...
-
Clinical Quality Assurance Manager
il y a 4 semaines
Les Ulis, France Ipsen Innovation (SAS) Temps pleinIpsen is a global biopharmaceutical group dedicated to improving lives and health outcomes through innovative medicines in Oncology, Neuroscience and Rare Disease. We are committed to discovering new treatments in areas with high unmet medical needs and improving the quality of life for patients. **Research and development are key elements of our strategy,...
