This position is no longer open for applications

CMC Regulatory Account & Line Manager (Temporary/Secondment)

We are looking for a new Regulatory Account Manager responsible for managing post approval CMC maintenance activities/projects. The position is based in Södertälje, Sweden.

As Regulatory Account 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 RIA and play a key role in the product leadership team.

You will be representing CMC Regulatory Compliance in global cross functional teams such as the Global Supply Teams (GST). You will also be expected to work closely with other regulatory functions in AZ, as well as the manufacturing sites.

The role

Line -management and development of a team of professional regulatory staff.

Responsible for defining the content of CMC submissions (NDA, MAA, JNDA, variations, Annual Reports, Licence Renewals etc) on behalf of CMCRC.

Provide AZ technical functions clear concise guidance on current regulatory requirements to 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, AZ 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 line management
• A minimum of 12 months experience in Pharmaceutical Production or  Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs

  
  Skills and Capabilities

• Experience of line management
• 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

  
  More information

  This is a temporary position for approximately 18 months.
  For more information about the position please contact Cecilia Just Davies +46 709 154549.

  Welcome with your application no later than October 22, 2017. Ignore the last date for application mentioned below.