CMC Regulatory Affairs Managers at AstraZeneca

We are currently seeking 2 dedicated CMC Regulatory Affairs Managers to join AstraZeneca in Södertälje!

Are you enthusiastic about applying science to deliver life-changing medicines? We are now looking for 2 CMC Regulatory Affairs Managers to join one of our CMC teams focused on biologics products at AstraZeneca in Södertälje! CMC Regulatory Affairs is a global function that manages all Chemistry, Manufacturing and Controls (CMC) regulatory activities across AstraZeneca’s global supply chain.

Don´t miss out on this opportunity – apply today!

Purpose, Offer and Benefits

This is a 1-year consulting assignment scheduled to commence no later than May. You will be employed by TNG during the assignment period. 

At AstraZeneca you will join a place built on innovation and creativity. Where different views and perspectives are encouraged and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

Your Responsibilities

As a CMC Regulatory Affairs Manager you will:

• manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges.
• 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.
• 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.

The Bigger Picture

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.

Our Expectations

• Degree in Chemistry, Pharmacy or Chemical Engineering, or equivalent experience
• Fluently spoken and written English
• Experience in CMC Regulatory Affairs
• 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

Desirable

• Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance