Regulatory affairs CMC to global pharma company

On behalf of our client, a global pharma company, QRIOS Life Science is now looking for a Regulatory CMC Associate for an exciting consultant assignment with start in the beginning of next year.

Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across global supply chain. We are looking for a Regulatory CMC Associate to the product team located in Södertälje.


About the position
As a Regulatory CMC Associate you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status up to approval of CMC documentation supplied by Operations to Global Regulatory Affairs.
You will work with colleagues and other functions within the company to obtain information that supports the generation of regulatory CMC documentation.

You may also support externalisation projects and transfer of CMC documentation to external partners.


Your profile
MINIMUM REQUIREMENTS - EDUCATION AND EXPERIENCE
Degree in Chemistry or Pharmacy or Chemical Engineering
Fluently spoken and written English and Swedish
Experience in Post Approval Regulatory CMC including CMC documentation authoring
Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs

SKILLS AND CAPABILITIES
Able to work collaboratively with customers and colleagues to achieve optimum outcomes
Knowledge of information and document management technology
IT software skills
Ability to work with short and / or changing timelines
Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
Excellent written and verbal communication skills
Experience from using Document Management systems