In this role you will safeguard the scientific integrity and regulatory alignment of Ferrer’s R&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 R&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
- volunteering opportunities
- versátil working model
- development and learning opportunities
- wellbeing benefits
- remuneration customization
- hybrid/office collaboration
Responsabilidades
- 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 R&D; programs, align timelines and milestones with strategic objectives, and enable efficient execution.
- Develop robust scientific justifications to support R&D; 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 R&D; value.
Requisitos principales
- 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 R&D; programs.