Regulatory CMC Associate, Operations Regulatory

Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across AstraZeneca’s global supply chain. We are looking for Regulatory CMC Associates to our product teams located in Södertälje.

We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to support compliant product supply through partnership with other AZ teams.


THE ROLE
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 ASTRAZENECA 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.

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

About ALTEN
ALTEN is a consulting company that develops and delivers expertise for world-leading companies with consultants in technology, IT and biochemistry. We are located in over 25 countries, have our headquarter in Paris and have more than 33,000 employees, of which 88 percent are engineers. In Sweden, we have over 1,700 employees and work from offices in twelve locations. Our clients are found in industries such as Automotive, Energy, Telecom, Industry, Aerospace & Defence and Life Science, where our consultants operate throughout the product development chain.

Welcome to read more about us at alten.se.