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Apply to JobJob ID255267BRPosition TitleRegulatory Affairs CMC Associate DirectorJob Description46! That is the number of development and marketed projects the Regulatory Affairs CMC Oncology 3 group is responsible for. In this global role, which covers development, registration, approval, and/or post approval stages of the product lifecycle, you will lead strategic and operational regulatory CMC activities for one or more of these projects. You bring a foundation of regulatory awareness and knowledge regarding small molecule drug substance and drug product development, manufacturing, and analytical testing, as well as a collaborative and patient-focused mindset. You will participate in global departmental initiatives, including continued improvement and knowledge management, and help to maintain compliance with global regulatory expectations.



YOUR RESPONSIBILITIES



Your responsibilities will include, but are not limited to:

• Formulate, lead, and drive global CMC regulatory strategy for development projects and/or marketed products with a focus on creativity and innovation, maximizing business benefit and balancing regulatory compliance

• Proactively communicate strategy, key issues, and any other critical topics to interdisciplinary project teams and management in regulatory, technical development, and technical operations departments

• Lead and drive global CMC submission activities for assigned projects, including change assessment, planning, authoring, review, submission, and health authority responses

• Keep knowledge up to date with regard to regulatory guidelines and requirements in global regions as well as for new technical trends

• Lead or participate in departmental initiatives aimed at continued improvement, knowledge management, and development of departmental and/or cross-functional procedures and business processesMinimum requirementsWHAT YOU’LL BRING TO THE ROLE:

• Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent with oral and written fluency in English

• Minimum 6 years’ experience in regulatory affairs and/or drug/biopharmaceuticals with a working knowledge of regulatory submission and approval processes for new chemical entities (NCE) and product lifecycle management

• Ability to manage complex CMC regulatory issues and requirements while leading/working in interdisciplinary teams, and thinking strategically, considering risks, risk mitigation, and compliance and business needs

• Well-developed planning, organizational, negotiation, and problem solving skills

• Clear communication with a collaborative and patient-focused mindset



YOU’LL RECEIVE:

Benefits you’ll receive include competitive salary and annual bonus, pension, 25+ days of annual holiday, Employee Share Option program, HQ campus facilities including restaurants/banking/gym/pharmacy/supermarket.



WHY CONSIDER NOVARTIS?

927 million. That’s how many lives our products touched in 2017. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?



We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.



We are Novartis. Join us and help reimagine medicine.DivisionGlobal Drug DevelopmentBusiness UnitREG AFFAIRS GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular

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