Head of Regulatory Affairs, Europe

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General DescriptionThe Head of Regulatory Affairs, Europe, is a leadership position that will be responsible for building and leading the regulatory team to develop and implement regulatory strategies to secure and maintain market access for product(s) in line with business objectives and in coordination with key internal stakeholders. The incumbent will provide leadership and strategic regulatory oversight for BeOne/BeiGene projects ensuring that the latest regulatory requirements and standards are met. The individual has departmental and corporate level responsibility for regulatory strategy. Externally, the individual will interface with EMA, and national regulators regarding drug development and registration strategies as appropriate. He/she also has line management, people development, and performance management responsibility. This role will be a member of the Global Regulatory Affairs Leadership Team and the European Leadership Team and is based in Basel, Switzerland.Essential Functions Of The JobEstablishes, develops, and manages effective/high-performance regulatory teams both via direct and indirect reporting structure.Builds partnerships with key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and expertise.Applies extensive knowledge of drug development and regulatory requirements both strategically and operationally to development projects and marketed products to support corporate goals.Establishes and maintains a trusting relationship with Regulators and ensures compliance with national regulations.Maintains up-to-date regulatory knowledge, state-of-art regulatory science, and deep understanding of regulatory policy in Europe and other major markets as appropriate, and assesses the impact on business and product development strategy. Ensures robust regulatory contributions to high quality of CTA’s and MAA’s in conformance with European and national regulatory requirements, to achieve timely submission and approvals.Defines processes and identifies tools to ensure efficiency in deliverables to expedite regulatory milestones.Represents BeOne/BeiGene at external forums, workstreams and Health Authority meetings contributing towards evolving regulatory requirements and recommendations.Role is based in Basel.Core Competencies, Knowledge & Skill RequirementsThorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends in EuropeExtensive regulatory experience with CTAs, MAAs, lifecycle management, interactions with Health Authorities, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.Strong business acumen and ability to make sound decisions that contribute positively to the businessVery strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g. new competition, shifting market environment) and the ability to balance short-term needs with long-term visionProven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalismStrong leadership of people and ability to lead a diverse team virtually for high performanceCommunication & Interpersonal SkillsExcellent verbal and written skills; able to analyze, define, and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholdersSkilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.Strong negotiating skills and ability to think creatively and develop creative solutionsProven ability to build trust and respect within the organization.Ability to prioritize and handle multiple projects simultaneouslyInteracts with external business partners and Regulatory authorities as appropriateDegree in life sciencesMinimum 15 years of experience in biotechnology or pharmaceutical industry and a minimum of 10 years of experience in a Regulatory capacity with a broad backgroundPreferred candidates will have Regulatory Affairs experience in EuropeSupervisory ResponsibilitiesYesGlobal CompetenciesWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClarityWe are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.