Director, Regulatory Systems

Title:

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:

We are seeking a highly motivated and experienced System Lead in Regulatory Operations to join our team. The successful candidate 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. This role will also encompass broader system responsibilities, integration of regulatory data during acquisitions, and other regulatory systems to ensure comprehensive and efficient regulatory operations.

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:

Oversee the implementation, maintenance, and optimization of Veeva Vault RIM Suite. Identify opportunities to enhance RIM capabilities and streamline regulatory processes. Collaborate with cross-functional teams to integrate RIM systems with other business applications. Manage the integration of various regulatory systems, ensuring seamless data flow and communication between platforms. Ensure the accuracy, integrity, and compliance of all regulatory data. Support business areas effectively and drive continuous improvement. Establish a regulatory systems roadmap and resource requirements.

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 integration during company acquisitions.
• Excellent project management and leadership skills.
• Strong analytical, problem-solving, and decision-making abilities.
• Excellent written and verbal communication skills.
• Ability to work in a fast-paced, dynamic environment.

Languages:

• Fluent English

Key Technical Competencies Required

QUALIFICATIONS:

• Proven cross-functional leadership track record and people management experience
• Proficiency in implementing, maintaining, and optimizing Veeva Vault RIM Suite.
• Strong understanding of global regulatory requirements and compliance standards.
• Ability to manage the integration of various regulatory systems and ensure seamless data flow and communication between platforms.
• Experience in integrating regulatory systems with business applications.
• Proficiency in defining strategy and overseeing the integration of regulatory systems within various tools
• Establishing a regulatory systems roadmap and resource requirements.
• Project management skills to handle multiple projects, develop plans, timelines, and budgets.
• Ability to communicate project status, risks, and issues to stakeholders effectively.
• Competence in managing software providers for project implementation, system upgrades, and support.
• Monitor industry trends and regulatory changes to proactively adjust processes and systems. Strong interest in Artificial Intelligence and new technology.
• Experience in ensuring seamless transition and integration of acquired regulatory information into existing systems. Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.