AdressCMC Regulatory Affairs Manager
Hays Life Science is now looking for two consultants to become CMC Regulatory Affairs Managers at AstraZeneca in Södertälje, Sweden. This is a consultant assignment for a year with a preferred start on 22nd of April.
CMC Regulatory Affairs is a global function that manages all Chemistry, Manufacturing and Controls (CMC) regulatory activities across AstraZeneca's global supply chain. We are looking for CMC Regulatory Affairs Managers to join one of our CMC teams focused on biologics products.
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 CMC Regulatory Affairs Manager, you will manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges. You will manage global CMC regulatory submissions, ensuring that project activities and documentation are delivered to the required standards across the product lifecycle, including keeping business wide electronic systems up to date to maintain regulatory status.
As a CMC RA Manager you will also contribute and own the regulatory CMC components of business-related projects having effective levels of interactive communication with stakeholders, collaborators and project team members to ensure that relevant timelines and regulatory commitments are communicated.
Minimum Requirements - Education and Experience
* Degree in Chemistry, Pharmacy or Chemical Engineering, or equivalent experience
* Fluently spoken and written English
* Experience in CMC Regulatory Affairs
Desirable
* Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance
Skills and Capabilities
* Understanding of Regulatory CMC dossier and requirements
* IT software and document management interest and skills, key systems Word and Veeva Vault
* Attention to details, highly organized, able to plan, progress and control tasks and own workload effectively and manage expectation of others
* Able to work with short and / or changing timelines
* Able to work collaboratively with customers and colleagues to achieve optimum outcomes
* High level understanding of GMP and working in a regulated environment
* Excellent written and verbal communication skills
