GRD CMC Technical Leader — Remote Europe

Chiesi Farmaceutici S.p.A.; Parma; In loco; EUR 62.000 - 75.000; Tempo pieno

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Parma, Italy, seeks a GRD Technical Leader to drive CMC development strategy, budget, and execution across projects partnering with CT and ETT workstreams.

You will align technical leadership with regulatory strategy and ensure quality for clinical trial materials and market approvals. The role requires a Master of Science and 10+ years in pharma, with strong leadership, CRO/CMO management, and experience in GMP and regulatory interactions.

Competenze

• Master's degree in a relevant field.
• Minimum 10 years of industrial pharmaceutical experience.
• Experience in development or manufacturing of drug substances/products or medical devices.
• Strong leadership and stakeholder management skills.
• Regulatory interactions with EMA and/or FDA; knowledge of GMP.

Mansioni

• Develop and drive the overall CMC development strategy and budget within GRD.
• Lead the ETT workstreams and coordinate internal/external resources.
• Ensure alignment with regulatory strategy and quality requirements for clinical trials and market approvals.
• Manage relationships with CMOs/CDMOs and external consultants.
• Provide technical review and approval of documentation for regulatory submissions.

Conoscenze

Leadership

Strategic planning

Regulatory knowledge

English proficiency

Stakeholder management

Formazione

Master of Science

Strumenti

MS Office

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Parma, Italy, seeks a GRD Technical Leader to drive CMC development strategy, budget, and execution across projects partnering with CT and ETT workstreams.

You will align technical leadership with regulatory strategy and ensure quality for clinical trial materials and market approvals. The role requires a Master of Science and 10+ years in pharma, with strong leadership, CRO/CMO management, and experience in GMP and regulatory interactions.