R&D Program Lead: Regulatory Risk & Portfolio Strategy

Ferrer; Barcelona; Híbrido; EUR 70.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Volunteer activities

Flexible working model

Development & learning opportunities

Wellbeing benefits

Customizable remuneration

Descripción de la vacante

Ferrer is seeking a senior scientific and regulatory professional to strengthen the R&D portfolio's integrity and lifecycle management in Barcelona. The role coordinates nitrosamine risk oversight, robustness processes, and cross‑functional program execution to maximize investment impact.

You will partner with Quality, Regulatory Affairs, Manufacturing, and Finance to ensure compliance with EMA/FDA guidelines, drive CAPAs, and support strategic investment decisions across the pipeline.

Formación

• Degree in Chemistry, Pharmacy, Biochemistry, or a related field.
• Minimum of 5 years of experience in the pharmaceutical industry.
• Hands-on laboratory experience ("white coat" background) is essential.
• Strong knowledge of late-stage pharmaceutical development and/or quality processes.
• Experience in risk management (nitrosamines knowledge is highly desirable).
• Familiarity with global regulatory requirements (EMA, FDA).
• Experience in industrial troubleshooting and problem-solving.
• Experience in pharmaceutical manufacturing environments (API and/or Drug Product) is highly desirable.
• Strong understanding of Quality Risk Management principles (ICH Q9).
• Experience in managing R&D programs

Responsabilidades

• Lead end-to-end nitrosamine risk assessment and mitigation strategies across Ferrer’s product portfolio.
• Ensure compliance with global regulatory requirements and evolving guidelines (e.g., EMA, FDA).
• Collaborate with Quality, Regulatory Affairs, and Manufacturing to maintain robust control strategies and lifecycle management plans.
• Provide scientific and technical support in the investigation of complex product and process-related issues.
• Contribute to root cause analysis, risk assessment, and definition of CAPAs.
• Facilitate cross-functional collaboration to ensure effective and timely resolution of issues.
• Support knowledge management and continuous improvement initiatives derived from troubleshooting learnings.
• Assist in the coordination and tracking of R&D programs across the development pipeline.
• Support program governance by ensuring alignment of timelines, milestones, and deliverables with strategic objectives.
• Collaborate across functions to ensure efficient execution of development programs.
• Develop and consolidate robust scientific and technical justifications to support R&D projects within strategic frameworks (e.g., PROFARMA, tax incentives, fiscal deduction programs).
• Prepare documentation and evidence packages required for external programs, ensuring compliance with regulatory and financial criteria.
• Collaborate with Finance, Regulatory, Scientific, and Strategy teams to ensure consistency and robustness of inputs used in investment justification and reporting.

Conocimientos

Cross-functional collaboration

Regulatory knowledge

Quality risk management

Project management

Analytical thinking

Educación

Degree in Chemistry, Pharmacy, Biochemistry, or a related field

Descripción del empleo

Ferrer is seeking a senior scientific and regulatory professional to strengthen the R&D portfolio's integrity and lifecycle management in Barcelona. The role coordinates nitrosamine risk oversight, robustness processes, and cross‑functional program execution to maximize investment impact.

You will partner with Quality, Regulatory Affairs, Manufacturing, and Finance to ensure compliance with EMA/FDA guidelines, drive CAPAs, and support strategic investment decisions across the pipeline.