Regulatory CMC Team Manager to AstraZeneca

CMC Team Manager




Temporary Team Manager, Operations Regulatory, GQSC



On behalf of AstraZeneca we are now looking for candidates for a 12 month (minimum) consultant assignment as a Temporary Team Manager for the Operations Regulatory, GQSC group. You will be employed by Dfind and this will be your first assignment. As our consultant you get a secure employment with collective agreements (Almega), fixed monthly salary and benefits such as healthcare, occupational health insurance, insurance, ITP pension and health care allowance.

Dfind Science & Engineering is a consulting and recruitment company specialized in science and technology skills. We arrange various events and training courses for our consultants that enable exchange of experience, networking and insight into working in different roles and companies. With us, you get a consultant manager who is committed to your assignment and career development.







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 timelines
• Experience of working with MAA´s
• Experience of line management is beneficial


Business: Dfind Science & Engineering

City: Södertälje

Job type: Full time

Deadline for applications: 2018-11-29

More information: Sofie Önnestam, sofie.onnestam@dfind.se, 073 343 99 61

Please send your application in English.

We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! We put great emphasis on personal suitability for this role.

Organization/Business description:

Dfind Science & Engineering is part of Randstad, one of the Nordic region's largest specialists within staffing, recruitment and outplacement.

Dfind Science& Engineering is specialized in recruitment and consulting providing competences within Life Science, Science and Engineering and is a company where people make all the difference. At Dfind Science & Engineering specialists are recruiting specialists!

All our recruitment consultants , consultants and sourcing managers have a technical or scientific background, combined with extensive networks within relevant communities and expertise within recruitment and HR. We understand our customers specific requirements and know how to find the best candidates. Through our passionate commitment and high degree of attentiveness we help people and businesses to grow and be competitive in a changing world.