Global Country Submissions Lead - Regulatory Strategy

ThermoFisher Scientific; Melbourne; In loco; AUD 120.000 - 160.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health & Wellbeing

Flexibility

Extra Leave

Charitable Giving & Volunteering

Learning & Development

Descrizione del lavoro

Thermo Fisher Scientific Australia is seeking a Senior Country Approval Specialist to manage local regulatory submissions and coordinate with investigators and regulatory authorities. The role involves developing submission strategies and ensuring alignment with global plans.

You will serve as the primary country contact, advise on MoH/EC strategy, and lead cross-functional coordination to accelerate site activations. A Bachelor's degree and 5+ years of regulatory experience are required.

Competenze

• Bachelor's degree or equivalent with relevant formal qualification.
• Minimum 5 years' experience in regulatory submission roles.

Mansioni

• Prepare and coordinate local regulatory submissions.
• Provide regulatory strategy advice to internal clients.
• Develop and implement local submission strategy.
• Serve as primary contact for investigators and authorities.
• Ensure timely submission communications and updates.
• Coordinate with internal departments to align site and submission timelines.

Conoscenze

Regulatory knowledge

Communication skills

Interpersonal skills

Attention to detail

Documentation quality

Negotiation skills

Team mentoring

Team player

Formazione

Bachelor's degree or equivalent

Descrizione del lavoro

Thermo Fisher Scientific Australia is seeking a Senior Country Approval Specialist to manage local regulatory submissions and coordinate with investigators and regulatory authorities. The role involves developing submission strategies and ensuring alignment with global plans.

You will serve as the primary country contact, advise on MoH/EC strategy, and lead cross-functional coordination to accelerate site activations. A Bachelor's degree and 5+ years of regulatory experience are required.