Senior CMC Consultant – Hybrid Global Regulatory Strategy

Scendea Ltd; Brisbane; Ibrido; AUD 120.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Generous bonus program

26 days annual leave

Employer pension contribution

Private healthcare insurance

Employee Assistance Programme

Employee Ownership Trust Scheme

Coaching and professional development

Descrizione del lavoro

Scendea Ltd. is seeking a Senior Consultant (CMC) to join our hybrid team, based in Australia (Brisbane) or the UK (Bishop's Stortford). You will provide strategic regulatory advice, lead CMC development plans, and coordinate global submissions while mentoring junior staff.

The role requires travel and periodic in-office work, with a minimum one day on-site per month. You will influence regulatory strategy from early development to marketing authorization, collaborate with clients, and deliver

Competenze

• Requires a strong scientific background with hands-on drug development and CMC experience.
• Experience leading multi-jurisdiction regulatory programs and interacting with authorities.
• Proven ability to mentor staff and lead regulatory strategy across projects.

Mansioni

• Provide strategic regulatory advice for CMC development of human medicines.
• Lead multi-country regulatory submissions and agency interactions.
• Manage project budgets and timelines, mentoring team members.
• Support business development through client engagements and proposals.

Conoscenze

CMC development

Regulatory strategy

Technical leadership

Global submissions

Mentoring & training

English communication

Formazione

BSc in a biomedical field or equivalent

PhD in biomedical field (desirable)

Descrizione del lavoro

Scendea Ltd. is seeking a Senior Consultant (CMC) to join our hybrid team, based in Australia (Brisbane) or the UK (Bishop's Stortford). You will provide strategic regulatory advice, lead CMC development plans, and coordinate global submissions while mentoring junior staff.

The role requires travel and periodic in-office work, with a minimum one day on-site per month. You will influence regulatory strategy from early development to marketing authorization, collaborate with clients, and deliver