CMC Strategy Lead: GRD Technical Leader (Remote)

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

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. is seeking a GRD Technical Leader to manage budget, strategy, and execution for CMC development and IMP supply. The role directs ETT workstreams, collaborates with CT and product teams, and leads external partners to drive development milestones and regulatory approvals.

The candidate will lead technical reviews, ensure GMP/compliance, and support long-term collaborations with CROs/CDMOs while aligning with Chiesi values and strategic goals.

Competenze

• Minimum Master of Science in relevant field.
• Minimum 10 years of relevant industrial experience in the pharmaceutical sector.
• Experience in development or manufacturing of drug substances, products or devices.
• Experience with EMA and/or FDA regulatory interactions.
• Experience with CMOs and CROs.
• GMP knowledge and good documentation practices.
• Strong leadership and problem-solving skills.
• Excellent written and verbal communication in English.
• Broad experience across development and manufacturing of pharmaceuticals.
• Familiarity with regulatory guidelines and industry standards.

Mansioni

• Budget, strategy and execution of CMC development and IMP supply for GRD portfolio.
• Lead ETT workstreams and organize internal/external competencies.
• Coordinate documentation packages for development phases.
• Review and approve technical documentation for regulatory submissions.
• Act as GRD CMC representative in project core teams.
• Manage external consultants and relationships with CROs/CDMOs.
• Ensure alignment with regulatory strategy and project milestones.

Conoscenze

Leadership

Regulatory knowledge

Communication

English proficiency

Formazione

Master of Science

Strumenti

MS Office

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. is seeking a GRD Technical Leader to manage budget, strategy, and execution for CMC development and IMP supply. The role directs ETT workstreams, collaborates with CT and product teams, and leads external partners to drive development milestones and regulatory approvals.

The candidate will lead technical reviews, ensure GMP/compliance, and support long-term collaborations with CROs/CDMOs while aligning with Chiesi values and strategic goals.