Title:
Senior Director , Head of Global Regulatory Operations

Company:
Ipsen Innovation (SAS)

Job Description:

Summary / purpose of the position

1.Define and execute strategies on:

-systems and tools overall architecture and inter-connections with the Corporate solutions, in collaboration with enterprise policies,

-data governances (rules, roles and responsibilities) across the Global Regulatory Functions,

-compliance objectives for the regulatory activities.

2.To take global leadership in elaborating, overseeing and coordinating overall Regulatory Operations infrastructures required to execute GRQ activities including publishing activities.

3.To develop and translate the portfolio expansion / licence to secure strategies, in close relationship with GRQ Leadership Team, horizontally with key functions (safety, IT) and vertically with local affiliates

4.Manage by exemplifying Ipsen Way of Being principles an international team of 20 employees in a highly evolving environment... and technologies transformation, and as core member of the GRQ Leadership team, to be a key stakeholder in Ipsen regulatory activities and initiatives.

Main responsibilities / job expectations

1.Leadership & team management

-To take global lead of Global Regulatory Operations teams and activities

-Work closely with the SVP GRQ to execute the Regulatory Operations strategy, monitor and oversee the activities of the team and ensure the Global Regulatory Operations are efficiently integrated within R&D

-Define the Global Regulatory Operations vision development and ensure its narrative, implementation and visibility

-Work with the SVP GRQ to define appropriate resourcing strategies to ensure adequate staffing, supported by robust business plans, recruiting new staff members and /or external partnerships solutions as required

-Structure the Global Regulatory Operations operating model including decision making process

-Act as Global Regulatory Operations representative at the Functions Leadership Team level for activities under R&D scope

-Ensure training and development of staff under his/her supervision

-Oversee direct reports in preparation and management of their responsibilities and assist as needed

-Responsible for having a broad perspective on external influencing issues and help bringing a regulatory culture / mindset

-Enhance Global Regulatory Operations team visibility and improve interactions with business functions (e.g. Regulatory Therapeutic Areas…)

-Contribute to Inspection Readiness and provide support to Audits and Inspections activities

-Ensure oversight and/or management of the third parties: contractors & Service Providers

2.Performance / Activity Oversight

-Promote accountability within the team, guiding the direct reports in preparation and management of their responsibilities and provide support when needed.

-Encourage cross collaboration between Global Regulatory Operations teams

-Responsible for ensuring outsourced activities are delivered on time and on budget. Responsible for identifying and alerting management regarding any service issues.

-Regulatory Intelligence: Responsible for monitoring the external environment to identify trends and assess potential impact on business and communicates this information to stakeholders in a timely and compelling way

-Responsible for promoting activities and processes to reinforce "good external influencing behaviors" in the GRQ organization

-Develop relevant KPIs to monitor Architecture activities, ensuring high level quality delivery and in a timely manner

3.Accountable for developing and providing best in class and up on running Regulatory Operations Systems Architecture to serve efficient Global Regulatory activities:

-Develop with department Head the architecture principles & vision: common set of principles across GRQ to improve the current eco-system and machinery, high-level, aspirational view of the target architecture

-Establish system governance for GRQ create formal, cross domains governance structure

4.Organise and supervise the compliance to the standards and laws applicable to GRQ domain

-Ensure adequate Regulatory Systems in compliance with Global Regulatory requirements

-Drive the response preparation of all Regulators requests, including inspection readiness

-Deliver performance & compliance indicators

5.Communication:

-Ensure timely and accurate communication on evolutions, upgrades, KPIs to all internal stakeholders (Regulatory Operations, RA community, GRQ LT, GPS)

6.Budget

-Prepare accurate budget and forecasts for Regulatory Operations activities. Follow up actual expenses.

7.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/her collaborators

Knowledge, abilities & experience

Education / Certifications:

•Ideally PhD or equivalent in life sciences

•Ideally degree in IT technologies

•Evidence of management/leadership education (MBA or executive trainings)

Experience:

•Ideal, at least 10 years’ experience managing a worldwide Regulatory team

•At least 15 years’ experience in Pharmaceutical Industry (R&D or Pharmacovigilance), 5 years’ experience working in regulatory affairs, experience in managing complex regulatory submissions

•Experience on Regulatory Tools Administration (mainly regulatory tracking Data base and EDMS)

•High level knowledge in IT tools used for electronic dossier management and publishing: electronic document management systems, publishing suites, regulatory tracking systems

•Experience in the Data management methodology implementation and Data integrity principles implementation.

•Experience in the management of regulatory data and the Regulatory Data Governance to ensure availability, usability, integrity and security of high-quality data for RA community

•Key business analyst skills

•Fluent with the review regulatory processes

Languages:

•Good oral and written communication skills

•Fluent English

•Fluent French

Key Technical Competencies Required

-Consistent ability to foster strong matrix working. Proven track record of facilitating groups of individuals to work together on innovative regulatory solutions.

-Strong interpersonal and negotiation skills with a proven ability to build strong personal networks, both within and outside Ipsen and use them to secure appropriate support and outcome for a project. Proven capability to influence decision makers both internally and externally

-Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Capable of seeing opportunities and revising process or approach to reduce barriers for others to be able to deliver more. Proven ability to lead change and communicate difficult messages effectively.

-Excellent written and oral communication skills and delivers all communication with clarity and impact. Commands attention through a range of communication styles.

-Shows a constant focus on improving performance in tasks. Challenges and questions ways of working to seek improved process.

-Strong leadership, clear vision, able to motivate and create nimble high performing teams (alternative: Prior people leadership experience with a track record of motivating and influencing others)

-Experience in managing teams and complex projects, as well as working in matrix settings

-Excellent communication skills, capable to deliver key communication with clarity and impact.

-Knowledge of IT systems and electronic submission requirements and processes

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

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
Gometz-le-Châtel France

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