rexx systems

Role Description The job of the Senior Portfolio Owner Regulatory Affairs is to provide end-to-end ownership of all regulatory and product-related activities, ensuring a strong product strategy that supports compliance, product availability, patient safety, and effective risk management. The role acts as the central point of accountability and escalation while coordinating operations, driving regulatory strategy, and providing disciplinary and functional leadership to the product team. By fostering cross-functional alignment, prioritizing operational activities, and involving relevant experts when needed, the role ensures effective collaboration and high-quality outcomes across departments. - Strategic Product & Regulatory Ownership: End-to-end responsibility for all regulatory and product-related activities within the portfolio. - Regulatory Strategy & Compliance Management: Develop and drive the global regulatory strategy while overseeing all submission activities, agency interactions, and regulatory processes across the entire product lifecycle. - Team Leadership & Operational Management: Provide disciplinary and functional leadership to the product team, including task prioritization, resource allocation, budget responsibility, and continuous development of team capabilities. - Cross-Functional Coordination & Stakeholder Management: Ensure strong cross-functional alignment with internal departments, acting as the central escalation point for regulatory and product-related topics. - Risk Management & Strategic Decision-Making: Assess complex regulatory and business risks and develop sustainable solutions under uncertain conditions. - External Partner & Outsourcing Oversight: Lead and oversee external service providers and outsourcing activities, ensuring quality, compliance, and performance. - Innovation, Governance & Continuous Improvement: Continuously evaluate regulatory developments, market trends, and available methodologies to improve processes and strengthen governance structures. Qualifications - Master’s degree in a relevant scientific or pharmaceutical discipline. - More than 10 years of professional experience in Regulatory Affairs within the pharmaceutical industry. Requirements - More than 10 years of proven leadership experience managing large, cross-functional Regulatory Affairs organizations at senior management level. - Strong ability to manage and resolve conflicts at high organizational and political levels. - Excellent indirect leadership, communication, and influencing skills across multiple hierarchical levels. Benefits - A growing company with a diverse, open working environment and employees from around 40 countries. - Individually customizable working models, including the option to work from another EU country for up to two months per year. 30 days of holiday. - Flexible benefits budget for increased company pension provision, fitness and health offers, or subsidies for travel and meal costs. - Access to the corporate benefits platform with discounts at hundreds of partner companies. - Internal and external training courses tailored to personal goals, as well as company and team events to strengthen cohesion.

Role Description Develop and Drive End-to-End Integration Strategy: - Development and implementation of a product integration strategy from contract signing to market launch, including early involvement during due diligence and alignment of teams on common goals, plans and timelines. Lead Cross-Functional Execution and Accountability: - Leading a diverse team from M&A, IMO, Commercial, Finance, Supply Chain, Regulatory Affairs, Quality, Medical and Legal. - Coordinating all workstreams for regulatory approvals, CMO onboarding, tech transfers as well as production and delivery within deadlines. - Identification and implementation of timeline optimizations and escalation of important topics to leadership. Manage Key External Stakeholders: - Accountable for ensuring external stakeholders (Divestment Partner, Contract Manufacturing Organizations, Sales and Distribution Partners) are effectively managed and aligned with integration objectives. Own Issue Resolution and Decision-Making: - Take active ownership of issue identification, resolution, and escalation. - Navigate complex interdependencies, competing priorities, and market-specific challenges (e.g., local re-testing, batch release, regulatory requirements). - Make informed decisions quickly, ensuring alignment across stakeholders and functions. Deliver Market Availability and Commercial Readiness: - Oversee implementation through to launch in key markets covering 90-100% of expected EBITDA. - This includes the transfer of production and packaging, approval by health authorities and the product launch from the new supply chain. Executive Reporting and Stakeholder Communication: - Provide strategic updates, risk assessments, and clear go/no-go recommendations to the department and company leadership. - Drive stakeholder alignment by translating project complexity into concise, action-oriented insights. Qualifications - Master's degree in Business Management, Business Administration or comparable. - At least 5 - 10 years of relevant professional experience in Project Planning and Risk Management in the pharmaceutical industry (must-have). - Excellent analytical and problem-solving skills with a strategic, results-driven approach. - A persuasive and resilient professional with excellent communication and relationship-building skills. - Confident in using standard MS Office programs and project management tools (MS Project, Planner etc.). - Fluent in English (written and spoken); proficiency in German (B1). Benefits - A growing company with a diverse and open-minded working environment with employees from around 40 different countries. - Flexible working models adapted to your needs (e.g. 100% remote working and up to two months from abroad within the EU possible), working time account with time off in lieu, 30 days' holiday. - Flexible benefits budget that you can use according to your individual preferences, such as a higher employer contribution to the company pension scheme, fitness & health offers or subsidies for travel or meal costs. - Discounts at hundreds of partner companies through access to the corporate benefits platform. - Internal and external training courses, tailored to your personal goals. - Company and team events to build relationships outside of the workplace and celebrate successes together.

Role Description Develop and Drive End-to-End Integration Strategy: - Development and implementation of a product integration strategy from contract signing to market launch, including early involvement during due diligence and alignment of teams on common goals, plans, and timelines. Lead Cross-Functional Execution and Accountability: - Leading a diverse team from M&A, IMO, Commercial, Finance, Supply Chain, Regulatory Affairs, Quality, Medical, and Legal (different departments). - Coordinating all workstreams for regulatory approvals, CMO onboarding, tech transfers, as well as production and delivery within deadlines. - Identification and implementation of timeline optimizations and escalation of important topics to leadership. Manage Key External Stakeholders: - The Integration Project Manager is ultimately accountable for ensuring external stakeholders (Divestment Partner, Contract Manufacturing Organizations, Sales and Distribution Partners) are effectively managed and aligned with integration objectives. Own Issue Resolution and Decision-Making: - Take active ownership of issue identification, resolution, and escalation. - Navigate complex interdependencies, competing priorities, and market-specific challenges (e.g., local re-testing, batch release, regulatory requirements). - Make informed decisions quickly, ensuring alignment across stakeholders and functions. Deliver Market Availability and Commercial Readiness: - Oversee implementation through to launch in key markets covering 90-100% of expected EBITDA. - This includes the transfer of production and packaging, approval by health authorities, and the product launch from the new supply chain. Executive Reporting and Stakeholder Communication: - Provide strategic updates, risk assessments, and clear go/no-go recommendations to the department and company leadership. - Drive stakeholder alignment by translating project complexity into concise, action-oriented insights. Qualifications - Master's degree in Business Management, Business Administration, or comparable. - At least 5 - 10 years of relevant professional experience in Project Planning and Risk Management in the pharmaceutical industry (must-have). - Excellent analytical and problem-solving skills with a strategic, results-driven approach. - A persuasive and resilient professional with excellent communication and relationship-building skills. - Confident in using standard MS Office programs and project management tools (MS Project, Planner, etc.). - Fluent in English (written and spoken); proficiency in German (B1). Benefits - A growing company with a diverse and open-minded working environment with employees from around 40 different countries. - Flexible working models adapted to your needs (e.g., 100% remote working and up to two months from abroad within the EU possible), working time account with time off in lieu, 30 days' holiday. - Flexible benefits budget that you can use according to your individual preferences, such as a higher employer contribution to the company pension scheme, fitness & health offers, or subsidies for travel or meal costs. - Discounts at hundreds of partner companies through access to the corporate benefits platform. - Internal and external training courses, tailored to your personal goals. - Company and team events to build relationships outside of the workplace and celebrate successes together.

Role Description Develop and Drive End-to-End Integration Strategy: - Development and implementation of a product integration strategy from contract signing to market launch. - Early involvement during due diligence and alignment of teams on common goals, plans, and timelines. Lead Cross-Functional Execution and Accountability: - Leading a diverse team from M&A, IMO, Commercial, Finance, Supply Chain, Regulatory Affairs, Quality, Medical, and Legal. - Coordinating all workstreams for regulatory approvals, CMO onboarding, tech transfers, as well as production and delivery within deadlines. - Identification and implementation of timeline optimizations and escalation of important topics to leadership. Manage Key External Stakeholders: - Accountable for ensuring external stakeholders (Divestment Partner, Contract Manufacturing Organizations, Sales and Distribution Partners) are effectively managed and aligned with integration objectives. Own Issue Resolution and Decision-Making: - Active ownership of issue identification, resolution, and escalation. - Navigate complex interdependencies, competing priorities, and market-specific challenges. - Make informed decisions quickly, ensuring alignment across stakeholders and functions. Deliver Market Availability and Commercial Readiness: - Oversee implementation through to launch in key markets covering 90-100% of expected EBITDA. - Includes the transfer of production and packaging, approval by health authorities, and the product launch from the new supply chain. Executive Reporting and Stakeholder Communication: - Provide strategic updates, risk assessments, and clear go/no-go recommendations to the department and company leadership. - Drive stakeholder alignment by translating project complexity into concise, action-oriented insights. Qualifications - Master's degree in Business Management, Business Administration, or comparable. - At least 5 - 10 years of relevant professional experience in Project Planning and Risk Management in the pharmaceutical industry (must-have). - Excellent analytical and problem-solving skills with a strategic, results-driven approach. - A persuasive and resilient professional with excellent communication and relationship-building skills. - Confident in using standard MS Office programs and project management tools (MS Project, Planner, etc.). - Fluent in English (written and spoken); proficiency in German (B1). Benefits - A growing company with a diverse and open-minded working environment with employees from around 40 different countries. - Flexible working models adapted to your needs (e.g., 100% remote working and up to two months from abroad within the EU possible). - Working time account with time off in lieu, 30 days' holiday. - Flexible benefits budget that you can use according to your individual preferences. - Discounts at hundreds of partner companies through access to the corporate benefits platform. - Internal and external training courses, tailored to your personal goals. - Company and team events to build relationships outside of the workplace and celebrate successes together.