Team Manager, Operations Regulatory

Företag Modis Sweden AB


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Team Manager, Operations Regulatory

Modis Life Science is looking for a Temporary Team Manager, Operations Regulatory, GQSC in Södertälje, Sweden. The consultant assignment will start 2019-01-01 and proceed for a minimum of 12 months.

Welcome with your application no later than November 28th

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.

We are looking for a temporary Team Manager responsible for managing post approval CMC (Chemistry Manufacturing & Control) maintenance activities/projects. The position is based in Södertälje, Sweden.

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 timelinesExperience of working with MAA´sExperience of line management is beneficial

About Modis:

We are constantly striving to support our customers and consultants to become successful. As a consultant, you are our top priority and when you need us, we will be there for you.

We will include you in our business and to our customers. You are our most important asset and for us to stay ahead you will take an active part in our business development and our offers to the market.

By becoming our colleague, your daily life as a consultant will be shifting with different assignments and projects in a variety of industries, systems and environments. Your experience will increase as well as your social and professional network. As a consultant, you are covered by collective agreements, insurance, occupational healthcare, healthcare and discounts on training cards. We believe in connecting people so having regularly social activities is key for us.

Modis delivers a wide range of services and competencies within IT, Engineering and Life Science. Our services are characterized by speed, simplicity and quality. Modis is represented in the United States, Canada, Europe with over 100 offices and with more than 35,000 colleagues on assignments each day.

If you have questions regarding the position, please contact:

Anders Olsson

E-post: anders.olsson@modis.se

Telefon: 073 684 72 48

Dela detta jobb

Team Manager, Operations Regulatory

Modis Sweden AB