Permanent | Full Time
.Regulatory CMC Lead – BiologicalUCB – Inspired by patients. Driven by science.Help us transform patients’ lives.About UCBAt UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We look to transform patients’ lives by pushing the boundaries of what is possible. With us, our talent makes the most of who they are, unlocking innovation and setting new standards for patients.Everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” And to find the answers, we connect globally with patients and their families living with the physical and social burdens of severe disease. These connections give us new perspectives, drive our innovation, and offer a hope for a new generation of therapies that will help to transform lives.To strengthen our Global Regulatory Affairs CMC & Devices team, we are looking to fill the position of: Global Regulatory CMC Lead – BiologicsWhat We OfferAn opportunity to:Lead teams in a very dynamic environment, mentor and coach staff through their development Take responsibility for the regulatory CMC support of biological and/or chemical entities throughout the Life-Cycle (early to late development, Clinical Trial Application writing and CTA support, writing of MAA/BLAs/NDAs and post approval variations)Define strategy, planning and preparation of (regional) of global submissions for assigned projects to deliver timely approvals to meet business needs Leading and/or provide regulatory CMC input to all Health Authorities (HA) interactions on CMC matters as agreed with the GRA-CMC & Devices Leadership TeamBe involved in shaping the internal and external Regulatory CMC & Devices environmentAbout the RoleYou will be responsible for:Developing and implementing the global regulatory CMC & Devices strategy and submission plans for assigned projects/products in line with business needs. managing product CMC & Devices projects by assuring Quality written global CMC documentation for submissions within agreed timelines. Negotiate on content of source documents so they are fit for Regulatory purposeTrain Technical and Regulatory teams on the technical regulatory needs and advocate for CMC & Devices in a matric environmentEnsuring effective communication of CMC regulatory strategy, risks, and overall plan for assigned projects to the Regulatory Affairs Teams, Supply &Technology Solution Teams and Patient Value teams Gather and interpret appropriate Regulatory CMC intelligence to increase value of GRA-CMC & Devices strategiesAbout YouYou should have:Motivated and Enthusiastic team player who can motivate teams in a virtual environment; works well in diverse teams but can also be hands on. Someone that likes working in a matrix environment across different cultures“Can do” attitude with pragmatic solutions while working within a regulated environmentProven track record of successful delivery of innovative CMC & Devices strategies for CTAs/marketing authorisations/Variations for new biological and/or chemical entities.Like to understand the broader environment, be a bridge between the different departmentsEducated preferably to a master’s level, in a relevant life science or technical related discipline Several years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 8 years of experience in Regulatory Affairs CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field. Experience in managing people, preferably in a culturally diverse companyAbout UCBUCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7 500 people in approximately 40 countries, the company generated revenue of € 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.
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