Team Manager to Regulatory CMC operations at AstraZeneca

We are looking for a Regulatory team manager responsible for managing post approval CMC (Chemistry Manufacturing & Control) maintenance activities and projects. This is a 12-months (minimum) consulting assignment at AstraZeneca in Södertälje. You will be line-managing a team of Regulatory CMC Managers/Associates in order to deliver the project portfolio for which the team is accountable. Do you have experience in Pharmaceutical Production, Quality Assurance, Quality Control or Regulatory Affairs and excellent leadership skills? Please don’t hesitate and send in your application today. Welcome to Poolia Life Science!

Job description
As Team Manager you will be line-managing a team of Regulatory CMC Managers and Regulatory CMC Associates in order to deliver the project portfolio for which the team is accountable.

You will be responsible for providing operational, tactical and strategic CMC regulatory expertise and direction to product and project teams in support of products throughout the product lifecycle.

You will report to Head of TA ONC and play a key role in the TA leadership team.
You will be expected to work closely with other regulatory functions in AZ, as well as manufacturing sites and Global Supply Chain & Strategy.


Responsibilities will include
Line management and development of a team of professional regulatory staff.
Responsible for defining the content of MAAs and Licence Renewals as well as other CMC submissions, e.g. variations and Annual Reports on behalf of Operations Regulatory.

Provide AZ technical functions clear concise guidance on current regulatory requirements to support business tactical and strategic planning.

Ensure expert recommendations and decisions relating to CMC for individual products/product portfolios including risk management and mitigation.

Ensure projects are delivered to agreed time-scales, AstraZeneca business requirements, compliance requirements and regulatory authority expectations worldwide.

Minimum Requirements - Education and Experience
• Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering
• Excellent written and verbal Swedish and English
• A minimum of 12 months experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
• Previous line management experience is beneficial

Skills and Capabilities
• Leadership skills
• Excellent communication skills
• Team working skills
• Ability to make effective decisions despite uncertainty and/or incomplete information to drive business outcomes
• Ability to establish fruitful relationships and maintain networks
• Ability to work with short and/ or changing timelines
• Experience of working with MAA´s
• Experience of line management is beneficial

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're 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. Here, employees are empowered to express diverse perspectives.