Regulatory CMC Manager at AstraZeneca

Are you a Chemistry or Pharmacy or Chemical Engineer and have worked within the pharmaceutical agencies, associations or pharmaceutical industry? Look here! Experis is now looking for 2 consultants for roles as Regulatory CMC Manager at AstraZeneca. You are welcome with your application!

Placering: 
Stockholm
Bransch: 
Teknik, Naturvetenskap
Antal tjänster: 
2

Regulatory CMC Manager, Operations Regulatory

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 - and are made to feel valued, energized and rewarded for their ideas and creativity.

Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across AstraZeneca's global supply chain.

We are now looking for a Regulatory CMC Manager to support CMC related activities for externalisation projects.

This role is available as a temporary contract and will be based in Södertälje, Sweden.

The role

The Regulatory CMC Manager provides CMC regulatory and compliance advice on regulatory post-approval submissions and project manages timely submissions of post approval CMC documentation.

You will represent Operations Regulatory in externalisation projects and provide input to project switch plans. As part of the role you will also create and review CMC dossiers for transfer to external partners, identify ongoing and upcoming CMC variations and provide Regulatory CMC support for a defined time immediately post MAH transfer.

You will be expected to use your regulatory knowledge to deliver to high standards, influence others and ensure the application of global CMC regulations and guidance within AstraZeneca.

The role expects an understanding of the Operations Function and how it contributes to achieving the objectives of the business as well as an understanding of the functions it interacts with. The role offers opportunities to work with global networks.

An understanding of activities needed in support of Marketing Authorisation Transfers is desirable.

Minimum Requirements - Education and Experience

  • Degree in Chemistry or Pharmacy or Chemical Engineering
  • Fluently spoken and written English and Swedish
  • Considerable experience within Pharmaceutical Agencies or Associations or in the Pharmaceutical industry (Regulatory Affairs or Pharmaceutical Production or Quality Assurance or R&D)
  • A minimum of 24 months experience in Regulatory Affairs preferably Post Approval Regulatory CMC

Skills and Capabilities

  • Project Management skills
  • Experience of working within a global environment
  • Experience of Marketing Authorisation Transfers
  • Able to work collaboratively with customers and colleagues to achieve optimum outcomes
  • Ability to work with short and/ or changing timelines
  • Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
  • Experience of working in a LEAN environment
  • Excellent written and verbal communication skills
  • IT skills and/or knowledge of information and document management technology

Experis

Experis has your career goals in focus with a long-term commitment in our consultants to create a balance between private life and work life. With us you get a secure employment with everything that contains; competitive salary, overtime compensation, vacation, occupational pension, insurance according to collective agreements, continuous contact and an annual meeting regarding your career with your consultant manager. Healthcare and wellness grants are examples of other things that we offer to all our employees.

Application and contact information

Please attach your CV and apply to this position through this web-page. Should you have any questions regarding the position or Experis, you are more than welcome to contact Talent Acquisition Specialist Viktoria Vershovsky at viktoria.vershovsky@se.experis.com