Arbetsbeskrivning

Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in securing 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 Description:

We are looking for a Senior Operations Regulatory CMC Specialist to join our dynamic team.

What you will work on:

• Manage and support global Chemistry, Manufacturing and Controls (CMC) regulatory submissions.
• Ensure timely and high-quality regulatory documentation and project deliverables.
• Collaborate with cross-functional teams, including regulatory affairs, manufacturing, and quality.
• Utilize regulatory databases such as RIM and ERV to manage submission workflows.
• Coordinate and communicate with internal and external stakeholders to align on regulatory strategies.
• Track and report project progress, risks, and issues to stakeholders.

What you bring:

• Bachelor’s degree in a scientific or technical discipline (e.g. Pharmacy, Biology, Chemistry, or related field).
• Solid knowledge and experience with regulatory requirements, preferably in both clinical and commercial settings.
• Proficiency in regulatory databases and electronic regulatory submission systems (e.g. RIM, ERV).
• Demonstrated experience in stakeholder and project management.
• Strong attention to detail and excellent organizational and communication skills.
• Ability to work independently and as part of a global, cross-functional team.