Senior Regulatory Affairs Executive

A bit about us:

Commercial teams support launches with sales, medical affairs and market access.

The Senior Regulatory Affairs Executive works with R&D, quality and clinical to build regulatory strategy and keep products compliant after launch. This position focuses on CMC sections for IND amendments and an upcoming NDA. You can work from home anywhere in Bulgaria. We have no office requirement.

In this role you will:

• Track submission timelines and commitments in Veeva Vault RIM or a similar system
• Assess design and manufacturing changes for regulatory impact and document the rationale
• File MDRs and support complaint and recall decisions with quality
• Keep regulatory files and correspondence organised and inspection ready

Required qualifications:

• 5-7 years of regulatory affairs experience in medical devices, pharma or biologics
• Able to travel up to 10 percent
• Familiarity with eCTD structure and submission publishing tools

Nice to have:

• Experience with Veeva Vault RIM
• Software as a medical device (SaMD) and cybersecurity submissions

Schedule: Monday to Friday, standard business hours

What you get:

€2,900 - €3,700 monthly

• Private medical care
• Extra annual leave days
• Life insurance
• Flexible hours
• Annual bonus

Please mention your notice period and expected salary.

Start: Immediately.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at Proizvodstvo Krastev EOOD.