Regulatory Affairs Specialist - CMC

About the company:

Clinical trials run at hundreds of sites, managed by our clinical operations group and CRO partners. Since 1980, the company has built manufacturing sites in Queensland and abroad.

The position:

We are adding a Regulatory Affairs Specialist - CMC to our operations team. Our operations team supports drug products in clinical trials across the US, EU and Canada. Our team is spread across 12 countries. Headquarters is in Gold Coast. Employment is through our payroll partner in the UAE. Salary is paid monthly in local currency. You will need some overlap with Australian Eastern time in the mornings. You get a company laptop and a headset before you start.

Main duties:

• Assess design and manufacturing changes for regulatory impact and document the rationale
• Track submission timelines and commitments in Veeva Vault RIM or a similar system
• Build regulatory strategy memos for new products and line extensions
• Write and compile Module 3 CMC sections in eCTD format
• Review labeling, IFUs and promotional materials for regulatory compliance and supported claims
• Monitor new guidance documents and summarise changes for the business
• File MDRs and support complaint and recall decisions with quality
• Coordinate with international distributors on country registrations

Minimum qualifications:

• 3+ years of regulatory affairs experience in medical devices, pharma or biologics
• Able to travel up to 10 percent
• Clear technical writing and careful editing
• Knowledge of ISO 13485 and ISO 14971 for device roles
• Familiarity with eCTD structure and submission publishing tools

Bonus points:

• Master's degree or PharmD
• RAC certification from RAPS
• Software as a medical device (SaMD) and cybersecurity submissions

Schedule: Monday to Friday, standard business hours

What we offer:

AED 21,500 to AED 28,000 monthly

• Paid parental leave
• 20 days paid time off
• Co-working space stipend

We look at every application, usually within a week.

Start: Flexible.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Jackson Biologics.