09 ago
|
Ferrer
|
Barcelona
Experteer Overview In this role you will safeguard the scientific integrity and regulatory alignment of Ferrer’s Ru0026amp; D portfolio, coordinating across Quality, Regulatory Affairs, and Manufacturing. You will lead nitrosamine risk oversight and contribute to robust decision-making that maximizes the impact of Ru0026amp; D investments. You’ll partner to maintain lifecycle management and ensure compliance with EMA and FDA guidelines. This role offers the chance to influence cross-functional programs and advance strategic initiatives in a hybrid work setting.Compensaciones / Beneficios
- Lead end-to-end nitrosamine risk assessment and mitigation across the portfolio, ensuring global regulatory compliance.
- Collaborate with Quality, Regulatory Affairs, and Manufacturing to maintain control strategies and lifecycle plans.
- Provide scientific support for investigation of complex product/process issues, contribute to CAPAs, and facilitate cross-functional resolution.
- Coordinate and track Ru0026D programs, align timelines and milestones with strategic objectives, and enable efficient execution.
- Develop robust scientific justifications to support Ru0026D projects within strategic frameworks and prepare required documentation for external programs.
- Collaborate with Finance,
Regulatory, Scientific, and Strategy teams to ensure robust inputs for investment justification and reporting.
- Act as a transversal role across departments to bridge scientific and business perspectives and maximize Ru0026D value.Responsabilidades
- Degree in Chemistry, Pharmacy, Biochemistry, or a related field.
- Minimum of 5 years of pharmaceutical industry experience.
- 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 EMA and FDA regulatory requirements.
- 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 Ru0026D programs.Requisitos principales
- volunteering opportunities
- adaptable working model
- development and learning opportunities
- wellbeing benefits
- remuneration customization
- hybrid/office collaboration
📌 R&D Program Manager (Barcelona)
🏢 Ferrer
📍 Barcelona