Director, Regulatory Systems
il y a 7 heures
**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
-
Expert, Cmc Regulatory
Il y a 3 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...
-
Alternance - Global Regulatory Affairs Operations
Il y a 5 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 2 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...
-
Financial Director
il y a 3 semaines
Issy-les-Moulineaux, Île-de-France Accor Temps pleinJob Title: Financial DirectorAccor is seeking a highly skilled Financial Director to join our team. The successful candidate will be responsible for developing and implementing financial strategies to achieve the hotel's objectives.Key Responsibilities:Reporting to the General Manager, the Financial Director will be responsible for managing the budgeting...
-
Sales Director
il y a 3 semaines
Issy-les-Moulineaux, Île-de-France Accor Temps pleinJob Title: Sales DirectorJob Summary: We are seeking a highly motivated and experienced Sales Director to join our team at Accor. The successful candidate will be responsible for leading and motivating junior team members to ensure yearly sales budget is achieved and surpassed. The Sales Director will also be responsible for adhering to the management...
-
Clinical Scientist
Il y a 5 mois
Les Ulis, France IPSEN Temps plein**Title**: Clinical Scientist **Company**: Ipsen Innovation (SAS) **Summary / purpose of the position** - Providing leadership and management within Clinical Development (CD) to provide scientific and clinical development support for products (assets) within assigned therapy area. - Support development and execution of medical & clinical strategy for...
-
Clinical Scientist
Il y a 5 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...
-
Group Safety Director
il y a 1 mois
Issy-les-Moulineaux, Île-de-France Transdev Temps pleinJob Title: Group Safety DirectorTransdev is seeking a highly experienced and skilled Group Safety Director to lead our safety efforts and drive a culture of safety excellence across our global operations.About the RoleThe Group Safety Director will be responsible for developing and implementing a clear safety strategy and culture across our countries,...
-
Financial Director
il y a 3 semaines
Issy-les-Moulineaux, Île-de-France Accor Temps pleinJob Title: Director of Finance & Business SupportJob Summary:The Director of Finance & Business Support is a key member of the core executive team, providing strategic leadership and functional guidance to Operations Leaders, Partners, Executive Committees, and Department Heads for optimal business decisions. This role interacts with ownership group, asset...
-
Group Safety Director
il y a 4 semaines
Issy-les-Moulineaux, Île-de-France Transdev Temps pleinJob Title: Group Safety DirectorTransdev is seeking a highly experienced and skilled Group Safety Director to lead our safety efforts and drive a culture of safety excellence across our global operations.About the RoleThe Group Safety Director will be responsible for developing and implementing a clear safety strategy and culture across our countries and...
-
Sales Director
il y a 2 semaines
Issy-les-Moulineaux, Île-de-France Accor Temps pleinAs Assistant Director of Sales - Leisure, you will be responsible for promoting and selling all hotel products, including rooms, catering, and banquets. Your tasks will include conducting site visits, FAM trips, and sales trips, as well as developing sales plans and maintaining customer relationships.Key Responsibilities:Conduct site visits, FAM trips, and...
-
Sales Director
il y a 3 semaines
Issy-les-Moulineaux, Île-de-France Accor Temps pleinJob Title: Sales DirectorJob Summary:We are seeking a highly motivated and experienced Sales Director to join our team at Accor. As a Sales Director, you will be responsible for leading and motivating junior team members to ensure yearly sales budget is achieved and surpassed.Key Responsibilities:Assist in the preparation of the yearly revenue and expense...
-
Sales Director
il y a 3 semaines
Issy-les-Moulineaux, Île-de-France Accor Temps pleinJob Title: Sales DirectorJob Summary:We are seeking a highly motivated and experienced Sales Director to join our team at Accor. The successful candidate will be responsible for leading and motivating junior team members to ensure yearly sales budget is achieved and surpassed.Key Responsibilities:Assist during preparation of the yearly revenue & expense...
-
Sales Director
il y a 2 semaines
Issy-les-Moulineaux, Île-de-France Accor Temps pleinJob Title: Sales DirectorJob Summary:We are seeking a highly motivated and experienced Sales Director to join our team at Accor. The successful candidate will be responsible for leading and motivating junior team members to ensure yearly sales budget is achieved and surpassed.Key Responsibilities:Assist in the preparation of the yearly revenue and expense...
-
Group Safety Director
il y a 3 semaines
Issy-les-Moulineaux, Île-de-France Transdev Temps pleinJoin Transdev's Leadership Team as a Group Safety DirectorTransdev is seeking a seasoned safety professional to lead our Group Safety team. As a Group Safety Director, you will be responsible for developing and implementing a clear vision that strengthens our safety strategy and culture across countries.Key Responsibilities:• Develop and implement a...
-
Group Safety Director
il y a 4 semaines
Issy-les-Moulineaux, Île-de-France Transdev Temps pleinJoin Transdev as a Group Safety DirectorTransdev is seeking a highly skilled and experienced Group Safety Director to lead our safety efforts across 19 countries. As a key member of our Strategy & Transformation leadership team, you will be responsible for driving our safety culture, improving safety performance, and rolling out international expertise.Key...
-
Director of Revenue Optimization
il y a 3 semaines
Issy-les-Moulineaux, Île-de-France Accor Temps pleinJob Title: Director of Revenue ManagementAt Accor, we are committed to delivering exceptional hospitality experiences to our guests. As a Director of Revenue Management, you will play a critical role in driving revenue growth and optimizing hotel profits.Key Responsibilities:Lead strategic planning and collaborate with hotel profit generation teams to...
-
Sales Director
il y a 4 semaines
Issy-les-Moulineaux, Île-de-France Accor Temps pleinJob Title: Sales ManagerAccor is seeking a highly motivated and experienced Sales Manager to join our team. As a Sales Manager, you will be responsible for leading and motivating junior team members to achieve yearly sales budgets and exceeding them. You will also be responsible for adhering to management standards and quality guidelines in the Department...
-
Commercial Systems Director
il y a 2 semaines
Issy-les-Moulineaux, Île-de-France Accor Temps pleinKey ResponsibilitiesThe Commercial Systems Manager ENA will be responsible for managing all commercial systems standards, processes, and implementation. This role will act as a one-stop shop for all activities related to commercial systems, liaising with internal and external partners and guiding RM community & hotel users on system usage and setup.Main...
-
Senior Clinical Monitoring Lead
Il y a 2 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...
