Regulatory Affairs Manager – CMC & Aseptic Manufacturing - 16437

Assignment Overview

We are looking for an experienced Regulatory Affairs Manager

What You Will Work On

Participate in project teams with internal stakeholders and external partners, including CMOs.up
Develop and drive regulatory strategies related to manufacturing and product changes.
Provide regulatory guidance and support to project managers and technical teams.
Perform regulatory impact assessments of proposed changes.
Prepare and manage regulatory submissions (variations, notifications, etc.).
Ensure projects are conducted in compliance with applicable regulatory frameworks and authority requirements.
Collaborate closely with Quality Assurance, validation, and technical functions to ensure regulatory alignment.

What You Bring

Strong experience in Regulatory Affairs within the pharmaceutical industry.
Deep knowledge of CMC (Chemistry, Manufacturing & Controls).
Documented experience in aseptic manufacturing environments.
Experience working with external manufacturers (CMOs).
Solid understanding of post-approval change management and regulatory submissions.
Ability to operate both strategically and hands-on within complex project environments.
Fluency in English (Swedish likely beneficial).

If this sounds interesting, please send your CV to cv@veritaz.se

Regulatory Affairs Manager – CMC & Aseptic Manufacturing – 16437