Head of Regulatory Affairs, Europe

General Description:
The 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 job:
- Establishes, 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 Requirements:
- Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends in Europe- Extensive 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 business- Very 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 vision- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism- Strong leadership of people and ability to lead a diverse team virtually for high performance

Communication & Interpersonal Skills:
- Excellent 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 stakeholders- Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.- Strong negotiating skills and ability to think creatively and develop creative solutions- Proven ability to build trust and respect within the organization.- Ability to prioritize and handle multiple projects simultaneously- Interacts with external business partners and Regulatory authorities as appropriate- Degree in life sciences- Minimum 15 years of experience in biotechnology or pharmaceutical industry and a minimum of 10 years of experience in a Regulatory capacity with a broad background Supervisory Responsibilities:
- Yes

Global Competencies

When 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 Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity

We 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, natio