Regulatory CMC Scientist - Small Molecule > Joboolo BE :
Société : UCB Lieu : Anderlecht Brussels Site source : Talent BE
What you’ll doProvide regulatory strategic and/or operational support for combination products or drug delivery devices.Provide regulatory CMC leadership on the cross functional sub teams (Global Regulatory Affairs (GRA) Teams and Supply & Technology Solutions (S&TS) Teams) and advise on best practices and/or supports Commercial Teams, as assigned by the GRA-CMC & Devices Leadership Team.Lead/Contribute and ensure adequate provision of regulatory CMC input to all Health Authority (HA) interactions on CMC matters in all regionsEnsure effective communication of CMC regulatory strategy, risks, and overall plans to GRA Teams, S&TS Teams and Development and Commercial Teams.Lead or provide input to internal regulatory business initiatives and/or cross functional work streams.Interested? For this position you’ll need the following education, experience and skills:
Bachelor’s Degree, Master’s preferred in a relevant life science or business-related disciplineMany years of relevant experience including a broad background of registration experience gained from working in the pharmaceutical industry, preferably in Regulatory Affairs CMC and/or in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field, or a regulatory authority in a CMC review capacity.Regulatory experience in combination products or drug delivery devicesProven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entitiesExtensive experience of participating in regulatory agency meetings on CMC mattersKnowledge of GMP requirements and standard systems (e.g.
change management systems and tools)Effectively lead globally diverse teams, meetings and discussions to deliver global/regional CMC sections of regulatory submissions for development and post-approval productsDemonstrated competence in contributing on cross-functional teams and operating within a matrix organisational structureEffective interpersonal, presentation and communication skills with established internal and external stakeholdersProven leadership, problem-solving ability, flexibility, influence, and effective teamwork skills.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! UCB AnderlechtBrussels
