Senior Operations Regulatory CMC Specialist - 12340

This post is also available in: Svenska (Swedish)

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.

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

Senior Operations Regulatory CMC Specialist – 12340