Submission Strategy Lead

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 Submission Strategy Lead (SSL) serves as the regional submission strategy, governance, and submission risk management lead for multi-country clinical studies conducted across the EMEA region providing regulatory intelligence related to clinical trial submissions and ethics requirements throughout the study lifecycle.

The SSL acts as subject matter expert in clinical trial submission requirements and operational regulatory implementation, with extensive knowledge of the EU Clinical Trial Regulation (CTR), CTIS processes, ethics committee requirements, and country-specific clinical trial submission frameworks across the EMEA region.

The SSL plays a critical role in submission governance by driving strategic submission decisions, building submission plans and timelines, monitoring critical path activities, proactively identifying and escalating risks, issues, delays, and trends across the study portfolio, analyzing RFIs and performance metrics, and leading continuous improvement initiatives to enhance submission quality, predictability, and speed.

Key responsibilities also include amendment impact assessment, cross-country risk management, regulatory intelligence, and escalation management. The SSL acts as the primary regional interface between Regional and Country teams for submission-related strategy, governance, and operational regulatory alignment, facilitating effective communication and decision-making across stakeholders.

In addition, the SSL contributes to submission activities portfolio-level oversight, continuous process improvement, standards development, quality governance initiatives, and submission innovation efforts aimed at enhancing submission effectiveness and accelerating study start-up across the EMEA region.

Success in this role requires strong strategic thinking, stakeholder management, influencing, communication, and leadership skills, as well as a thorough understanding of ICH-GCP, EU CTR, ethics committee processes, country-specific clinical trial requirements, and internal quality standards.

Essential Functions of the job:  

Clinical Trial Submission Strategy & Regulatory Intelligence:

• Acts as the primary regional point of contact for submission governance, submission strategy and operational regulatory matters for ethics committee/Part II requirements.
• Partners with Regulatory Affairs, Regional Study Teams, Country teams and/or CROs where applicable, to develop efficient and compliant cross-country submission strategies.
• Advises on submission-related considerations impacting study start-up, including regional specific requirements, submission sequencing, Member State Section implications, and operational feasibility.
• Interprets and communicates evolving clinical trial regulatory requirements and submission processes to support consistent implementation across the EMEA region.
• Identifies emerging regulatory trends, risks, and opportunities that may impact submission timelines, approvals, or study start-up activities.

Submission Governance & Risk Management

• Leads regional submission governance activities across assigned portfolio/studies.
• Establishes cross-country alignment on submission plans, submission timelines, critical milestones, dependencies, and implementation approaches, in collaboration with local teams, Regulatory Affairs colleagues, and any other relevant stakeholders.
• Identifies, assesses, and consolidates submission-related risks, supports cross-country decision-making and operational regulatory challenges across countries.
• Develops regional mitigation strategies and escalation plans in collaboration with Country teams, Regional Study Teams, Regulatory Affairs and/or CROs where applicable.
• Serves as the regional escalation lead for complex submission, ethics, and operational regulatory issues.

Amendment Impact Assessment & Implementation Governance

• Leads regional amendment impact assessments.
• Facilitates structured review of regulatory and operational impacts of protocol amendments.
• Consolidates country feedback, identifies risks and dependencies, and develops regional recommendations.
• Supports cross-functional decision-making for high-impact amendments.
• Escalates significant implementation challenges and submission risks to Global stakeholders as appropriate.
• Oversees regional governance and alignment during amendment implementation.

Core Package Quality & Cross-Country Alignment

• Leads regional review and consolidation of core package feedback to ensure alignment across participating countries.
• Facilitates discussions on country-specific requirements, document customization needs, and implementation considerations.
• Consolidates regional comments, recommendations, and escalations for communication to Global stakeholders.
• Ensures consistent interpretation and implementation of core package requirements across countries.
• Acts as the regional coordination point for complex submission-related decisions requiring cross-country alignment.

Regional & Country Alignment

• Facilitates alignment between Regional Study Teams, Regulatory Affairs, functional stakeholders, Country teams and/or CROs where applicable.
• Supports timely and compliant execution of submission activities across the EMEA region, where applicable.
• Represents submission and regulatory regional perspectives, risks, and implementation considerations in governance forums and strategic discussions.
• Drives resolution of cross-functional issues that may impact submission readiness, approvals, or study start-up timelines.
• Ensures effective communication and information flow between Regional and Country stakeholders.

Portfolio Oversight, Quality & Continuous Improvement

• Provides portfolio-level oversight of submission risks, trends, and key operational regulatory challenges across the EMEA region.
• Identifies opportunities to improve submission processes, governance models, timelines, and study start-up efficiency.
• Contributes to the development of standards, tools, guidance documents, and best practices supporting submission excellence.
• Supports quality and inspection readiness initiatives related to clinical trial submissions and regulatory documentation.
• Captures submission lessons learned and drives continuous improvement initiatives.
• Mentors and supports the development of colleagues within the submission functions.

Education Required:

• Bachelor’s degree (or equivalent) or higher in a scientific, clinical trial, medical, or healthcare discipline* (e.g., Registered Nurse) with a minimum of 5 years of experience in clinical operations, study start-up, or regulatory affairs.
• Experience in biotech, pharmaceuticals or a related field in the biotech/pharmaceutical industry is essential.

*Exceptions may be made to candidates with appropriate Clinical Operations or Regulatory Affairs experience.

Computer Skills: 

Good to Intermediate knowledge of Microsoft Word, Excel, PowerPoint, SharePoint, Microsoft Teams, and Outlook.

Demonstrates working knowledge of Clinical Trial Management Systems.  

Other Qualifications: 

•      Fluent in written and verbal English

•      Strong interpersonal skills, can-do attitude, and problem-solving skills.

•      Able to multi-task and meet compressed timelines.

Travel:

Limited to no business travel expected.

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.