Regulatory Affairs Manager CMC & Aseptic Manufacturing 16437

Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in ensuring the perfect talent fit. With a proven track record of successful partnerships with top companies, we have rapidly grown our presence in the USA, Europe, and Sweden as a dependable and trusted resource within the IT industry.

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).