Head of Regulatory Systems Management

il y a 4 semaines


Les Ulis, Île-de-France Ipsen Innovation (SAS) Temps plein

Position

Job Title: Head of Regulatory Systems Management

Division / Function: Global Regulatory Affairs – Regulatory Operations

Manager (Name, Job Title): Head of RegOps, GRA

Overview of the Role

We are in search of a dynamic and seasoned leader in Regulatory Operations to take charge of our Regulatory Information Management (RIM) systems. The ideal candidate will play a pivotal role in enhancing our RIM capabilities, ensuring the integrity of regulatory data, and fostering agility in our regulatory workflows through the utilization of Veeva systems. This position will also involve broader system oversight, integration of regulatory data during acquisitions, and management of various regulatory systems to guarantee efficient operations.

Key Responsibilities

  1. Leadership of the System Team: You will guide and mentor a team of regulatory operations experts, promoting a collaborative and inclusive environment. Your leadership will ensure that the team is equipped to achieve compliance and operational objectives, including their professional growth and performance evaluations.
  2. Management of RIM and System Enhancements: Oversee the deployment, upkeep, and enhancement of the Veeva Vault RIM Suite. Identify avenues for improving RIM capabilities and optimizing regulatory processes. Collaborate with cross-functional teams to ensure RIM systems are integrated with other business applications.
  3. Stakeholder Engagement: Collaborate with senior stakeholders to propel regulatory initiatives and ensure alignment with the organization’s strategic goals. Participate in projects aimed at improving submission processes and outcomes.
  4. Promotion of Agility and Continuous Improvement: Advocate for agility in regulatory operations by implementing innovative solutions and best practices. Lead initiatives focused on continuous improvement to boost operational efficiency.
  5. Compliance Reporting and Communication: Establish comprehensive reporting systems to convey compliance status, risks, and system performance to upper management.
  6. Development of Data Standards and Policies: Conduct regular audits and evaluations to ensure compliance of regulatory data with global health standards.
  7. Contribution to Regulatory Operations Leadership: Play an active role in shaping the strategic direction and decision-making processes within the department.
  8. Data Integration Management: Oversee the integration of regulatory data during company acquisitions.
  9. Project Management: Handle multiple projects related to system and data integration concurrently, ensuring timely and successful outcomes.
  10. EHS Responsibilities:
    • Adhere to and enforce relevant EHS regulations and procedures.
    • Foster EHS awareness within teams to support the effective functioning of the EHS management system.
    • Engage in accident prevention initiatives.
    • Ensure that all team members complete mandatory EHS training.

Required Knowledge, Skills & Experience

Education / Certifications:

  • Advanced degree in Life Sciences, Information Technology, Regulatory Affairs, or a related discipline.

Experience:

  • At least 10-15 years of experience in regulatory operations within the pharmaceutical sector.
  • Expertise in Veeva Vault RIM Suite, eCTD management systems, and other regulatory platforms.
  • Strong grasp of global regulatory requirements and compliance standards.
  • Proven success in enhancing RIM capabilities and implementing process improvements.
  • Experience managing regulatory data integration during company acquisitions.
  • Exceptional project management and leadership abilities.
  • Strong analytical, problem-solving, and decision-making skills.
  • Excellent written and verbal communication capabilities.
  • Ability to thrive in a fast-paced, dynamic environment.

Language Proficiency:

  • Fluent in English.

Essential Technical Competencies

  • Demonstrated cross-functional leadership and people management experience.
  • Proficiency in implementing, maintaining, and optimizing Veeva Vault RIM Suite.
  • Comprehensive understanding of global regulatory requirements and compliance standards.
  • Ability to manage the integration of diverse regulatory systems and ensure seamless data flow.
  • Experience in aligning regulatory systems with business applications.
  • Project management skills to oversee multiple projects, including planning, timelines, and budgeting.
  • Capacity to effectively communicate project status, risks, and issues to stakeholders.
  • Monitor industry trends and regulatory changes to proactively adjust processes and systems.


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