CMC Regulatory Affairs Manager at AstraZeneca

We are currently seeking an ambitious CMC Regulatory Affairs Manager to be part of AstraZeneca in Södertälje!

Do you have a high level understanding of Good Manufacturing Practice (GMP) and experience from working in a regulated environment? Great! AstraZeneca in Södertälje is now looking for a CMC Regulatory Affairs Manager to join the team. Don´t miss out on this opportunity – apply today!

Purpose, Offer and Benefits

This is a 1-year consulting assignment starting in January. You will be employed by TNG during the assignment period.

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.

Your Responsibilities

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.

The Bigger Picture

The right candidate should possess self-motivation, the ability to take initiative, and a genuine interest. The role involves working with various systems, requiring a keen interest in this aspect.

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
• Pharmaceutical Production, Quality Assurance, Quality Control, or Product Maintenance would be advantageous