Experis Engineering are now looking for a Regulatory CMC Manager for AstraZeneca in Södertälje! In this position you will be working in their Operationals Regulatory department, which is a global function that manages all Chemistry, Manufacturing and Controls post-approval regulatory activities across AstraZeneca's global supply chain. Do you want to become a part of Experis and join our team of life science consultants? Welcome with your application today!
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 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.
What can Experis offer you?
As a consultant at Experis Engineering we are happy to offer you the opportunity to develop your knowledge within different fields at some of Sweden's leading companies. At Experis we are very proud of our consultants and together we find the right career-paths and challenges for you!
We do have high expectations on you, and in return we offer you great possibilities and opportunities in your work-life. We work together by setting plans for you on how we can collaborate for you to reach your own personal goals and develop professionally.
At Experis we strive for a good work and life balance. You will get a permanent employment in accordance with union agreements, including overtime payment, vacation, occupational pension and insurances.
Contact and application:
Please send in your CV as soon as possible through the link on the page. We do not have the possibility to receive applications through e-mail, but should you have questions about the job or the role as a consultant at Experis, please feel free to contact Talent Acquisition Specialist Camilla Forssberg at Camilla.Forssberg@se.experis.com or 08-736 19 23.