CMC Regulatory Affairs Specialist (Post-Approval)

Company: Eblex Group

Location: Kalisz, Poland
Work mode: Hybrid
Seniority: Mid level
Employment type: Contract
Posted: Yesterday
Offer language: English

Job description

Workplace type: Hybrid

Location: Poland

Employment type: Contract

Duration: 12-months

Description

We’re working with a global pharmaceutical company that is building a team of CMC Regulatory Affairs Specialists to support post-approval work on its marketed products. The portfolio is mainly small molecules and traditional vaccines.

This is a hands-on role. You’ll be preparing and updating the CMC documentation behind changes to approved products, working with the client’s regulatory team. The role isn’t agency facing and doesn’t involve regulatory strategy.

What you’ll be doing

Preparing and updating Module 3 and Module 2.3 documentation for post-approval changes
Supporting variations and supplements for marketed products across the EU, US and other markets
Assessing the regulatory impact of manufacturing and quality changes
Supporting renewals and annual reports
Working with manufacturing, quality and technical teams to gather and check data for submissions
Keeping regulatory documentation accurate and up to date

What the client is looking for

Hands-on experience in CMC regulatory affairs, preparing or updating Module 3 documentation for post-approval changes
Experience with marketed products approved under a New Drug Application (NDA), Biologics License Application (BLA) or Marketing Authorisation Application (MAA)
Experience with small molecules and/or traditional vaccines
A good working knowledge of the CTD format and of EU and US post-approval requirements
Comfortable handling a steady volume of changes accurately and to deadline
Fluent English

Good to have