Regulatory Affairs CMC, Global Regulatory Leader - EU, US and RoW Strategic leadership role!

Reference: TM260820B

Expiry Date: 28-12-2021

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time


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Job Description

Regulatory Affairs CMC, Global Regulatory Leader - EU, US and RoW Strategic leadership role!

ADV Talent Partners are recruiting for a Global Regulatory Leader to provide Global product leadership, setting the CMC regulatory strategy and driving it through to implementation with regular interactions and negotiations with Health Authorities, working in a matrix environment within a multi-disciplinary and multicultural organization.

Our client is a growing pharmaceutical company that is at the forefront of innovation with a friendly cultural and a strong regulatory team that really operates as a team, supporting each other when there are submissions or peaks in workload.

Decisions are yours to make, as there is a high level of empowerment and autonomy within the team. You need to be independent, calm, cool and collective, prepared to give guidance to team members and other technical teams.

This is a permanent role based in Brussels, easily commutable via public transport or via car. The role comes with a competitive salary, short and long-term incentive programs as well as car allowance, some flexibility to work from home 2-3 days a week and a lucrative stock options package.

Our client is searching for an experienced Regulatory Affairs CMC professional (at Associate Director level) who enjoys being technical and hands-on, who is happy leading and managing their own projects, authoring IMPDs, working on PIPS, taking the lead for products in early or late development, giving strategic input, providing input and sometimes leading Scientific advice meetings and also supporting MAA/NDA’s and global expansion projects.

Ideally you will be self-motivated, strategic and pragmatic, focused on internal and external customer satisfaction. In return you will receive great job satisfaction, wonderful work-life balance and the opportunity to work in a friendly, transparent and dynamic organisation.

Experience needed: Regulatory Affairs CMC focused product development and lifecycle management experience for regulatory strategy for either the EU or US and/or emerging markets. You will need to have a number of regulatory achievements around defining and implementing regulatory strategies for development compounds and marketed products in EU, US and/or International markets.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 or Oli Dimitrov on +44 (0)207 801 3388 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380.

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