RA Workstream Lead

• Manage Marketing Authorization (MA) / Licenses & QP transfer to Buyer

• Supervise RA CMC activities for pending CMC applications and CMC change control, MSR

• Link with RA Clinical expert for pending Clinical applications, Q&A

During the divestment early phases, the RA Lead might support the deal team by providing ad hoc input during the third party due diligence and negotiation processes (set-up of the divestment legal framework with Buyer).

The RA lead will manage the RA team, composed of RA Coordinators. The RA Lead will be the contact person towards the Buyer project RA counterpart and ensure reporting / escalation to the respective internal and external governing bodies.

After decision of the discontinuation by VIB / VET, the RA lead will assume responsibility to coordinate the license withdrawal process, in consultation with LOCs.

Your responsibilities:

• Leads & participate to internal / external governance meetings

• You lead (bi-)weekly DBU RA staff meetings: track progress against KPI for the different projects

• You represent RA in DBU asset weekly meetings with Asset Lead: report achievements, risks & issues, trade-offs, next steps

• You are RA SPOC in projects staffs and with external & internal partners (GSK RA/GIO/QA/R&D) & LOCs

• Supervision of RA team of DBU

• Performance follow-up/evaluation, coaching, workload priorities set-up

• You ensure team members roles & responsibilities are well defined (including back-ups), ensure visibility within and outside the DBU on the team’s remit

• Onboarding: you ensure fit-for-purpose welcome packs and training matrix are available, all coordinators have the required information to fulfil the job mission

• You set-up regular 1/1 meetings with coordinators to track progress, provide leadership, coaching & challenge and discuss possibilities for development (additional training, responsibilities, possibilities for job rotation)

• Continuous improvement:

• You will adhere to DBU golden processes, suggest improvements to current policies based on lessons learned

• You Customize ways-of-working, processes, communication channels to Buyer needs

• You feed and maintain the knowledge management for the activities in his / her field of responsibility; ensure RA-related information is readily available to internal / external team members (maintain internal / external team sites)

• You engage stakeholders located in MPUs / department (Wavre & Rixensart) and abroad. Convince them vis-à-vis GSK-Vaccines / DBU decisions, contractual obligations, procedures or processes, while remaining diplomatic and maintaining motivation

• With support of PMO, you organize regular workshops for assessment of the asset team / RA’s performance in scope of the Internal Control Framework

• Resource management: estimate & track resources with support of Finance Lead & Cross-assets PMO; pro-actively highlight additional resource needs and ensure appropriate resource prioritization across projects in the DBU portfolio

• You establish trustworthy relationship with colleagues RA leads and asset leads,

• You support the yearly objectives setting exercise organized by the PMO team

• Responsible for the overall coordination within regulatory to fulfil obligations as per deal team agreement

• Lead the weekly regulatory divesture project team meetings within GSK (team & RA)

• GSK RA SPOC in weekly/Monthly meetings within GSK and with Buyer (Staff, Implementation Committee, S&OP, VSOT, JPT…)

• Manage Marketing Authorization (MA)/ Licenses & QP transfer to Buyer

• Supervise RA CMC activities for pending CMC applications and CMC change control, MSR

• Link with RA Clin expert for pending Clin applications, Q&A

• Provide status on obligations and tracking of activities to the Transfer team and the purchaser- provide regular reports are requested by the purchaser & senior mgt

• Control any outsourced activities outsourced (e.g. to Parexel)

• Supervise data segregation, transfer and archiving

• 
  For Discontinuations:

• Supervise licenses removals with LOCs

• Supervise RA CMC activities for pending CMC applications, CMC change control, OPAL and MSR

• Support Global Trademark Team in trademark/domain name removal

• Support GSK LOCs in communications with MOH/BOH on product discontinuation

• Align and co-ordinate activities, upon need, with VCT RA department

Why you?

BasicQualifications:

We are looking for professionals with these required skills to achieve our goals:

• Master degree in Life sciences and/or manufacturing/RA

• Regulatory experience and knowledge covering global markets, is an important asset to be able to discuss global regulatory strategy and requirements with other business partners and LOCs

• Experience with regulatory document management system and GSK IT tools

PreferredQualifications:

If you have the following characteristics it would be a plus:

• Regulatory experience and knowledge covering global markets, is an important asset to be able to discuss global regulatory strategy and requirements with other business partners and LOCs

• Autonomous

• strong sense of urgency and organizational credibility