AstraZeneca Pharmaceuticals LP Head of CMC RC Regulatory Intelligence Team in Södertälje, Sweden

As head of the CMC RC Regulatory Intelligence Team you will be a prime driver of the strategic direction for the Regulatory Intelligence team and will lead and manage an efficient and effective team to deliver global post-approval CMC Regulatory advice and direction.

You will ensure effective planning and information sharing activities with the key customer interface groups (within Operations, GRAPSQA and Commercial) and CMCRC to support regulatory strategies, issue resolution and continuous supply.

In addition, you will also ensure performance standards that support maintenance of the licence to operate. By developing senior level contacts, in particular with Global Regulatory Affairs, Global Operations, Regional Supply organisation and Marketing Companies, you will resolve issues that occur and to drive longer term improvements.

There is a requirement to set priorities and manage a high rate of change. You will instigate and actively manage change and uncertainty with a high degree of autonomy.

You will spend time leading cross functional, or global projects or representing Operations on leading edge projects.

As head of the CMC RC Regulatory Intelligence Team you will be a member of the CMC Regulatory Compliance (CMCRC) Leadership team and will see the delivery of key consistent Regulatory advice and projects as day to day activity and the essential requirement of the role. They will be required to work closely with other members of the CMCRC Leadership Team to ensure consistent delivery and high quality interactions with all interface groups globally.

Key Accountabilities

  • A global role with the need to develop international contacts across a number of AZ functions (including R&D, Commercial and Operations). There will be a need to handle sensitive, international relationships, eg in markets such as Japan, where well developed cultural sensitivity will also be required.

  • Accountable for timely communication of information to and from CMCRC to inform regulatory strategies and secure supply.

  • Accountable for the resource allocation associated with delivering efficient output.

  • Responsible for ensuring right people are in place to meet planned efficient output

  • Responsible for management, development and co-ordination of a global team of professional staff, with key Regulatory and Technical skills.

  • Responsible for driving and delivering performance standards and improvements, issue resolution, through ongoing change and uncertainty

  • Responsible for the tactical and operational implementation of supply/demand requirements which arise from the Key Customer groups

  • Accountable for maintaining Lean principles within area of responsibility

  • Accountable for optimising the performance of the Regional team globally

  • To effectively deploy resource within the team and in co-operation with other Business Units in CMCRC to deliver the business Objectives.

  • Accountable for creating value through others; to lead, manage and develop staff to a shared defined standard.

  • Accountable for adherence to SHE and compliance standards within own function.

Required Skills & Knowledge

  • Graduate status

  • Significant experience of pharmaceutical and/or manufacturing and/or Regulatory.

  • Regulatory CMC knowledge

  • Thorough understanding of GMP requirements.

  • Breadth of knowledge of manufacturing, project, technical and regulatory management.

  • People management, customer service and change/project implementation.

  • Excellent written and spoken English

  • Core Capabilities

  • Flexibility/Adaptability

  • Influencing

  • Initiative

  • Collaborative

  • Professional Capabilities

  • Regulatory Knowledge

Preferred Skills & Knowledge

  • Business, financial and supply chain understanding/awareness

  • Budget management

  • Lean manufacturing principles, understanding, experience and practitioner

  • Product and process knowledge

  • Professional Capabilities

  • End to End Supply Chain Principles

  • Lean Approach

  • Quality & Compliance Management

  • Quality Risk Management Team Development

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.