Vice President, Regulatory Affairs, Europe and International job opportunity at BeOne Medicines.

Home Jobs In Switzerland Tag: Regulatory Affairs, Europe and International Vice President, Regulatory Affairs, Europe and International position at BeOne Medicines


DatePosted 30+ Days Ago bot
BeOne Medicines Vice President, Regulatory Affairs, Europe and International
Experience: General
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Regulatory Affairs, Europe and International

Copy Link Report
degreeGeneral
loacation Basel, Switzerland
loacation Basel....Switzerland

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 Description: The Vice President, Europe and International Regulatory Affairs (APAC and New Markets, excluding USA, China and Japan), is a leadership position that will be responsible for building and leading the regulatory groups 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, will sit on the GRA leadership team and represent regulatory on the European cross functional leadership team. Externally, the individual will interface with EMA, national regulators and international organizations regarding drug development and registration strategies and provide insights to the organization of evolving regulatory policy and its impact to BeOne/Beigene’s business. He/She also has line management, people development, and performance management responsibility across a broad geographic area. Essential Functions of the job: Establishes, develops, and manages effective/high performance regulatory groups and 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 Establishes and maintains a trusting relationship with the Regulators by enforcing transparency in communications and ensuring compliance with national regulations Leads the regulatory team by creating a supportive environment that enables and empowers team members to collaborate and deliver high quality work Provides high level strategic and operational regulatory direction and mentorship on projects including, but not limited to, general regulatory strategies, regulatory requirements for clinical studies and Marketing authorizations, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interaction strategies. Applies extensive knowledge of drug development and regulatory requirements both strategically and operationally to development projects and marketed products to support corporate goals and improve global regulatory processes. Maintains up-to-date regulatory knowledge, state-of-art regulatory science, and deep understanding of regulatory policy globally, and assesses the impact on business and product development strategy. Ensures RA’s contribution to high quality of CTA’s and MAA’s in conformance with national regulatory requirements, and to the timely submission and approvals Support the establishment of new affiliates aligned with BeOne/BeiGene’s geographic footprint. Support the development and execution of local country regulatory strategy and life cycle management. Leverages new technologies and regulatory mechanisms to enable efficient submissions with a fungible team that supports the local markets robustly with new and evolving processes to be defined. 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 and other markets, preferably with a strong oncology focus. Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/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 Willingness to explore the use of new technologies and processes to streamline deliverables. 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 Supervisory Responsibilities:  Yes Computer Skills:   Microsoft office applications, Internet, Access to internal portals (e.g., Veeva Vault), Access to external portals (e.g., EMA portals), use of AI and other emerging tools Other Qualifications: NA    Travel:  When needed 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, 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.

Other Ai Matches

Senior Director, Field Medical Excellence (office based) Applicants are expected to have a solid experience in handling Field Medical Excellence (office based) related tasks
remote-jobserver Remote
Associate Director, Global Technology Solutions, Governance, Risk, & Compliance, NA & LATAM Applicants are expected to have a solid experience in handling Global Technology Solutions, Governance, Risk, & Compliance, NA & LATAM related tasks
remote-jobserver Remote
Director, Clinical Development-Biotech Unit Applicants are expected to have a solid experience in handling Clinical Development-Biotech Unit related tasks
Sales Training Manager, Customer Excellence, Japan Applicants are expected to have a solid experience in handling Customer Excellence, Japan related tasks
remote-jobserver Remote
Entity Controller - Latin America (Pharmaceutical Industry Experience Preferred) Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Field Medical Advisor Saudi Applicants are expected to have a solid experience in handling Job related tasks
Associate Director, Senior GBS Controller Lead Applicants are expected to have a solid experience in handling Senior GBS Controller Lead related tasks
remote-jobserver Remote
Director, Market Access France Applicants are expected to have a solid experience in handling Market Access France related tasks
Associate Event Coordination Manager, Customer Excellence, Japan Applicants are expected to have a solid experience in handling Customer Excellence, Japan related tasks
remote-jobserver Remote
Associate Director, Global Regulatory Project Management Applicants are expected to have a solid experience in handling Global Regulatory Project Management related tasks
remote-jobserver Remote
Associate General Counsel, Head of R&D Legal Applicants are expected to have a solid experience in handling Head of R&D Legal related tasks
remote-jobserver Remote
Associate Director, Medical Writer - Publications Applicants are expected to have a solid experience in handling Medical Writer - Publications related tasks
remote-jobserver Remote
Summer Internship: R&D Quality Data Insights Intern (Remote) Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Summer Internship: Digital Strategy and Enablement Intern Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Director, Corporate Affairs & Communications Applicants are expected to have a solid experience in handling Corporate Affairs & Communications related tasks
(Senior) Manager, Clinical Site Budget Planning Applicants are expected to have a solid experience in handling Clinical Site Budget Planning related tasks
EDC Administrator II Applicants are expected to have a solid experience in handling Job related tasks
Marketing Executive Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Director, Global Value, Access & Pricing; Solid Tumors, Pipeline Applicants are expected to have a solid experience in handling Global Value, Access & Pricing; Solid Tumors, Pipeline related tasks
Sales Innovator 【MR】 (Job Level: Specialist ~ Associate Manager) Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Director, GCO Program Lead (GCPL) Applicants are expected to have a solid experience in handling GCO Program Lead (GCPL) related tasks
Summer Internship: Process Engineering Intern (Onsite - Hopewell, NJ) Applicants are expected to have a solid experience in handling NJ) related tasks
remote-jobserver Remote
Medical Science Liaison Applicants are expected to have a solid experience in handling Job related tasks