Regulatory CMC Managers

On behalf of our client, AstraZeneca, we are now looking for two Regulatory CMC Managers for temporary assignments in Södertälje. This role offers great opportunities for you to work with global networks, as a member of the CMC Regulatory Compliance organization within the company. CMC Regulatory Compliance is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain. The assignment which is full-time will start as soon as possible with the duration to December 31, 2018. Selections and interviews are held on an ongoing basis, so please submit your application as soon as possible.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we are more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration.

The role
The role of Regulatory CMC Manager is focused on Post Approval Regulatory Chemistry, Manufacturing and Control (CMC) strategy and delivery within our CMC Regulatory Compliance Department.
Main purpose of the role
To produce and manage the production of CMC documentation for designated commercial products at various stages of product life-cycle, in the required format and to the agreed timetable. To ensure that key stakeholders are kept informed of relevant timelines and regulatory commitments for those products. To work as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate

Accountabilities/Responsibilities
• The Regulatory CMC Manager provides CMC regulatory and compliance advice on regulatory post-approval submissions and project manages timely submissions of post-approval CMC documentation.
• As a Regulatory CMC Manager you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status.
• As Regulatory CMC Manager you will be expected to use your regulatory knowledge to deliver to high standards, influence others and ensure the application of global CMC regulations and guidance.
• The role offers opportunities to work with global networks.

Minimum Requirements - Education and Experience

Essential requirements:

• Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering
• Considerable experience in the Pharmaceutical industry, for example Pharmaceutical Production or Regulatory Affairs or Quality Assurance and R&D.
• Fluently spoken and written English and Swedish
• Project Management skills
• Excellent written and verbal communication skills
• Experience of working within a global environment.
• Team working skills, Flexibility, Adaptability, Influencing, Initiative
• Previous experience of working in a Regulatory CMC environment.

Preferable requirements:

• Experience of working with international markets.
• Experience of working in a LEAN environment.
• IT skills and/or knowledge of information and document management technology and electronic/paper publishing software