GHU Regulatory Operations Manager at Sanofi

JOB PURPOSE

• Coordinate overall regulatory management of the GHU Unit with the Head of Africa and GHU

Key Accountabilities

• Coordinate overall regulatory management of the GHU Unit
• Lead operation activities and coordinate interactions with all involved functions (GRA, GHU, M &S, Legal etc)
• Support the GRA Lead in management meetings.
• Ensure that the optimal strategy is defined, Translate strategy into operational plan.
• Build & monitor macro-calendars to allow optimal progress and decision making.
• Manage risks / interdependencies across GenMed & GHU, Functions and within GRA and develop risk mitigation plans.
• Consolidate findings, recommendations, and deliverables.
• Leverage and engage resources across the organization to ensure the implementation waves are completed as per agreed timelines.
• Monitor the associated budget.
• Facilitate interaction and communications within GRA and with key Stakeholders.
• Support the development of communication plan.
• Ensure regular and appropriate communication to GRA LT and Support the GRA Lead in sponsor/Steering Committee meetings.

ABOUT YOU:
Education:

• Bachelor’s degree in healthcare/ Business/ Project Management

Experience & Knowledge:

• Minimal 6-year experience in the pharmaceutical industry, in Regulatory Affairs (global, regional or local).
• Experience working within an international company with a complex organizational environment.
• Wide exposure of transversal work with colleagues from different function ie. Regulatory and non-regulatory organisation (PV, medical, commercial, business development, supply chain etc)
• Sound understanding of Affiliate and Regional ways of working and Sanofi processes.

Core competencies /skills:

• Act for Change
• Cooperate Transversally
• Strive for Results
• Commitment to Customer
• Think Strategically
• Make Decisions
• Teamwork ability: good interpersonal & communication skills
• Ability to work in a matrix organisation
• Business and customer orientation
• Networking and influencing skills
• Strong organizational and leadership skills
• Strong Project Management skills
• Strong cultural awareness, problem solving, digital awareness.

Language:

• Good level of reading, spoken and written competency in 1 or more languages (other than English) would be an added advantage