Global Regulatory Lead
il y a 4 jours
Make your mark for patients
We are looking for a Global Regulatory Lead to join us in our Global Regulatory team, based in any of our Brussels (Belgium), Slough (UK) or Atlanta or Raleigh (US) offices.
About the role
The Global Regulatory Affairs Leader (GRL) provides regulatory leadership to assigned Mission and/or asset. The GRL leads the global Regulatory Strategic Team (RST) for assigned projects. This role will be accountable for the global regulatory strategy and oversight of implementation/execution in alignment with the Regional Regulatory Leads and other RST members.
The GRL is the primary contact point within UCB for any regulatory questions related to the assigned Mission and/or asset and is informed of and supports any key (planned) interactions with health authorities. The role is also responsible for leading and coordinating Mission regulatory budget and Practice resource discussions on behalf of the PVU and the GRA practice for assigned projects.
Who you'll work with
You will report into the Head of EU Regulatory Affairs
What you'll do
Serve as the Regulatory point of contact on the assigned Mission/PST with senior management and/or at other internal meetings providing the agreed global regulatory strategic recommendations and risk assessment for key projects. May serve as the Global Regulatory representative on other relevant governance teams representing the agreed global regulatory functional view. Accountable for the timely development and implementation of the global regulatory strategy and plan(s) designed to meet the needs of the business and patients for assigned Missions and/or projects (to deliver timely product milestones (e.g. HA meetings, new indications, etc.), ultimately leading to approval with a viable label meeting the needs of patients and the business). Accountable for delivering all regulatory milestones related to the assigned Mission including assessment of the approvability of the program submissions together with global regulatory risk mitigation measures (supported by the regions as appropriate). Accountable for the review of global/regional submission key documents (as applicable) and ensuring global alignment of key messages in line with Mission/PST objectives. Identify any potential risks along with possible contingencies to ensure the most appropriate submission timing leading to the earliest possible and most optimal approval of key deliverables. Accountable for ensuring the regional regulatory strategy for the specific product(s) are consistent with the business objectives, have been negotiated (if appropriate) with the appropriate regulatory authorities and that the regulatory risks have been identified.I nterested? For this position you'll need the following education, experience and skills :
Bachelor's degree Several years' experience in pharmaceutical regulatory affairs. Knowledge of global regulatory procedures and legislation for overall drug development, regional regulatory experience, clinical trial submission, product registration, line extension and license maintenance. Global regulatory experience is a plus. Global and integrated cross-functional view into pharmaceutical project management and drug development/approval and commercialization. Ability to appreciate multiple cross-functional elements contributing within drug development and ability to develop an adequate and coherent supportive global/local regulatory strategy. Good track record of (contributing to) delivering regulatory approvals.Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
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