CMC Regulatory Affairs Associate - Södertälje

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 CMC Regulatory Affairs Associate to join our dynamic team.
What you will work on:
Generate CMC (Chemistry, Manufacturing, and Controls) documentation to support lifecycle submissions, ensuring compliance with regulatory requirements.
Maintain electronic systems across the organization to keep regulatory status up to date.
Play a crucial role in externalization projects, facilitating the transfer of CMC documentation to external partners.
Collaborate with internal colleagues and external partners to gather necessary information for regulatory CMC documentation.
Manage maintenance and change control of external partners’ CMC documentation.

What you bring:
Hold a degree in Chemistry, Pharmacy, Chemical Engineering, or possess equivalent experience.
Proficiency in both spoken and written English and Swedish.
Prior experience in Pharmaceutical Production, Quality Assurance, Quality Control, Product Maintenance, or Regulatory Affairs.
Familiarity with Document Management systems, with a willingness to utilize and expand your expertise.
Strong attention to detail, exemplary organizational skills, and the ability to effectively plan and manage workloads, meeting both personal and others’ expectations.
Adaptable and capable of working within tight timelines and adapting to changing priorities.
Collaboration skills, enabling effective teamwork with customers and colleagues to achieve optimal outcomes.
In-depth understanding of GMP (Good Manufacturing Practice) and experience working in a regulated environment.
Proficiency in CMC Regulatory matters.
Excellent written and verbal communication skills.
Competency in IT software applications.