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License to Operate Lead

Position Summary

• Leads and ensures oversight of GxP areas, including but not limited to Quality, Pharmacovigilance, Medical Information and Regulatory activities across the affiliate
• Serves as an advocate of areas of expertise and is ultimately responsible for the upskilling of the people in his/her network through development and coaching

Key Responsibilities

Drug Regulatory Affairs Head

Strategy/Planning

• Shape the regulatory environment by taking a leadership role in industry associations on regulatory policy and regulations; taking regulatory convergence into consideration
• Contribute to and influence global regulatory strategies, considering local regulation and business needs
• Own regulatory intelligence gathering and dissemination across the Affiliate; involving regional and global organizations, when appropriate
• Lead Regulatory Affairs input into cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)
• Lead and develop innovative, risk-based regulatory strategies and work plans for all products across the Affiliate to accelerate access in alignment with global

Filings

• Lead and provide strategic oversight of execution of all regulatory filing activities across product life cycles, which may involve performing some of the work of Drug Regulatory Affairs staff
• Lead contact and negotiation with local HAs and internal stakeholders to build and cultivate trusted partnerships
• Ensure regulatory filings are aligned with commercial and supply needs to assure business continuity
• Significantly influence internal and external stakeholders for successful regulatory outcomes

Regulatory Compliance

• With your team, develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards
• Ensure regulatory inspection-readiness for the Affiliate, including leading or participating in internal/external regulatory audits
• Ensure all Affiliate regulatory activities comply with Roche global standards and local regulations

Other

• Oversee and guide end-to-end local product packaging and labelling from a regulatory perspective
• Where applicable, oversee review and approvals of promotional materials to provide regulatory input and guidance across the Affiliate
• As applicable, provide oversight of shipment clearance/QA release of Affiliate materials/products
• With your team, support local market access activities from a regulatory perspective

Pharmacovigilance Oversight

• Work in close collaboration with the local LSR to maintain oversight of the management of safety information, safety risk management and all other pharmacovigilance (PV) activities, ensuring PV medical compliance (Roche policies and procedures, global and local regulatory requirements) and inspection readiness

Quality Assurance Oversight

Work in close collaboration with the regional LQR to

• Monitor the implementation, maintenance and improvement of the quality systems deviations, change control, risk assessment, risk management, audit process, staff training and correlation with Roche’s global policies
• Establishes and communicates quality objectives
• Update the Annual Quality Plan

Clinical Operations Oversight

Work in close collaboration with Country Study Manager to

• Keep oversight for all assigned studies at regional/country level
• Ensure compliance to relevant processes and GCP principles
• Lead local quality/compliance reviews, internal audits, & regulatory inspections, ensuring inspection readiness at all times and completion of CAPA for allocated studies

Roche Mandatory Responsibilities

• Respects and implements the values of the company Integrity, Courage and Passion
• Complies, along with the team, with all Roche Corporate Business principles, Code of Conduct, policies and practices
• Maintains awareness of the company’s requirements to fully report adverse events and other reportable drug safety and product complaint information
• Respects all mandatory rules regarding occupational health and safety, as well as instructions on protection against fire and other hazards, provided by the employer/designated workers
• Implements improvements of business value, by initiating and/or identifying innovative opportunities for continuous enhancement and/or increasing the competitive advantage of the business

Education & Experience

• University degree as Medical Doctor; other HCPs (e.g. pharmacist) or human life science degree with the relevant experience might be considered, provided that other employees with a medical degree are accessible within the medical department
• Pharmaceutical medicine training is appreciated
• Proven results in people leadership and talent development in a multicultural environment
• Experience working in a matrix environment
• Advanced knowledge of English, both written and spoken
• Advanced knowledge of Microsoft Office suite Word, Excel and PowerPoint
• External stakeholders’ engagement ( Health authorities)

Key competencies

• Strong leadership skills has proven experience of building and cultivating relationships with key partners/stakeholders
• Visionary Articulates a bold, shared vision for her/his chapter and the whole Affiliate that is centered on the patient to deliver our “North Star”, embeds and projects this vision in all internal & external interactions
• Architect Evolves and develops functional roles and forms and empowers teams that make great decisions
• Catalyst Removes obstacles, prioritizes to create clarity and focus; collaborates externally to solve bottlenecks. Engages with all team members and the network above the country to shape structures, processes and behaviors; additionally engages externally side by side with GM and other business functions to continuously improve the patient journey
• Coach Helps everyone in the network building the skills and mindset they need to succeed; coaching and being coached
• Proven track record of effective decision-making makes good business decisions and exercises sound judgment
• Proven track record for consistently meeting or exceeding financial and other quantitative targets, as well as qualitative goals, for large departments/teams in the pharmaceutical/biotechnology industry
• Ability to use superior written and oral communication skills, including verbal and presentational skills, to persuade and influence both internally and externally
• Strong customer and patient orientation/focus
• Outstanding change management skills and a proven track record of effectively driving organizational change and innovation
• Outstanding influencing skills consistently extracts optimized business results through skilful collaboration with others, is an inspiring leader
• Encourages team & organization to challenge status quo and find innovative solutions, thinks out-of-the box
• Organizational skills and time management can prioritize multiple tasks and goals to ensure timely and high-quality accomplishment;
• Demonstrated ability to build and maintain relationships with both internal and external stakeholders including executives
• Understand political process and be able to work effectively with multiple and diverse external interests
• Ability to readily master new health policy issues and identify priorities and positions based on business needs