Senior Regulatory Submissions Specialist - Country Lead

ThermoFisher Scientific; Sydney; On-site; AUD 120,000 - 170,000; Full time

Benefits offered by this job

Health & Wellbeing

Flexibility

Extra Leave

Charitable Giving & Volunteering

Learning & Development

Job summary

Thermo Fisher Scientific Australia seeks a Senior Country Approval Specialist to manage local regulatory submissions and coordinate with MoH/EC authorities within a global strategy. You will guide local regulatory strategy, liaise with investigators and regulators, and oversee cross-functional teams to ensure timely site activations.

The role requires strong documentation skills, regulatory knowledge, and the ability to mentor team members while maintaining high standards of compliance and

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 5+ years of experience in regulatory affairs or related field.
• Excellent oral and written communication skills; ability to convey complex information clearly.
• Strong knowledge of local MoH/EC regulatory requirements and submission processes.
• Ability to mentor junior staff and lead cross-functional teams.

Responsibilities

• Prepare, review and coordinate local regulatory submissions (MoH, EC, other local applications) aligned with global strategy.
• Provide local regulatory strategy advice to internal clients.
• Develop and implement local submission strategies with cross-functional oversight.
• Serve as primary country contact for investigators and regulators to ensure timely submissions.
• Coordinate with internal departments to align site activities with submission timelines.
• Aim to achieve target cycle times for site activations.
• Maintain regulatory knowledge and ensure compliance with SOPs and guidelines.
• Mentor SIA team members and promote teamwork and quality.

Skills

Regulatory submissions

Regulatory strategy

Stakeholder management

Documentation accuracy

Regulatory guidelines knowledge

Communication skills

Team mentoring

Negotiation skills

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree or equivalent

Job description

Thermo Fisher Scientific Australia seeks a Senior Country Approval Specialist to manage local regulatory submissions and coordinate with MoH/EC authorities within a global strategy. You will guide local regulatory strategy, liaise with investigators and regulators, and oversee cross-functional teams to ensure timely site activations.

The role requires strong documentation skills, regulatory knowledge, and the ability to mentor team members while maintaining high standards of compliance and