Global Regulatory Portfolio Simplification Coordinator - VIE Contract

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Global Regulatory Affairs (GRA) team within the General Medicine Global Business Unit (GBU) as Global Regulatory Portfolio Simplification Coordinator VIE and you’ll support to drive the ambition of GRA General medicines and seeks opportunities to evolve the organization and portfolio, bringing to the optimal efficiency. This position is primarily aimed to provide support with the activities focused on the simplification of portfolio, i.e., divestment and pruning. 

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

• Support divestment lead with pre-closing activities for divestment projects and post-closing regulatory work-stream as part of the divestment projects..
• Support the development of regulatory strategy including Marketing Authorization Transfer plan and the transfer of regulatory responsibilities, including MAT plan implementation, local dossier transfers to the partners, and management of regulatory information internally and externally.
• May represent Global Regulatory Affairs and provide regulatory support to key stakeholders, and support or lead internal and external regulatory requests by collaborating with regulatory and cross-functional stakeholders.
• Collaborate with the regulatory stakeholders to receive relevant regulatory updates & information and assess impacts at various stage of the divestment projects including MA transfer process.
• May support pruning initiatives originating from the Global Portfolio Rationalization (GPR) process and / or divestment projects.
• Ensure timely communications of relevant topics and impacts to the project teams and up through GRA senior Management.
• Research and analyze regulatory information and maintain current regulatory knowledge of regulatory procedures and changes globally.
• Ensure compliance with all internal and external requirements and procedures and may propose improvement to operating policies/processes, as appropriate.

About you

Experience:

• First experience in Regulatory Affairs, preferably in pharmaceutical industry.

Soft and Technical skills:

• Good communication, analytical, presentation and negotiation skills.
• Proactive with problem-solving mindset.
• Ability to work within multi-functional environment.
• Ability to manage multiple projects with strict timelines.
• Proficient in MS: Word, Excel, PowerPoint.
  

Education:

• Master’s Degree in Regulatory Affairs, Pharmacy, Life Science (Chemistry, Biology etc.).
  

Languages:

• English fluent, French is only a plus.