Regulatory CMC Manager to Astra Zeneca in Södertälje
Experis Engineering Huvudkontor / Biologjobb / Södertälje
Observera att sista ansökningsdag har passerat.
Visa alla biologjobb i Södertälje,
Salem,
Ekerö,
Nykvarn,
Botkyrka eller i
hela Sverige Visa alla jobb hos Experis Engineering Huvudkontor i Södertälje,
Botkyrka,
Huddinge,
Järfälla,
Sundbyberg eller i
hela Sverige Experis Engineering offers technical competence of managers and professionals through consulting, recruiting and project solutions. By combining our industry experience with our knowledge of the human potential, we both get individuals and businesses to grow and develop. Experis Engineering is located at 30 locations in Sweden and in more than 50 countries worldwide.
Experis Engineering is seeking for Astra Zeneca a Regulatory CMC Manager for a consultancy assignment starting immediately. The assignment runs until the end of the year with good chances of extension.
The Regulatory CMC Manager role focuses on Post Approval Regulatory Chemistry, Manufacturing and Control (CMC) strategy and delivery within our CMC Regulatory Compliance Department.
Your work
To produce and manage the production of CMC documentation for designated commercial products at various stages of product life-cycle, in the required format and to the agreed timetable. To ensure that key stakeholders are kept informed of relevant timelines and regulatory commitments for those products. To work as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate.
This role will be based in Södertälje, Sweden.
Accountabilities/Responsibilities
• 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.
• As a Regulatory CMC Manager you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status.
• As Regulatory CMC Manager 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.
• The role offers opportunities to work with global networks.
Your Profile
• Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering
• Considerable experience in the Pharmaceutical industry, for example Pharmaceutical Production or Regulatory Affairs or Quality Assurance and R&D.
• Fluently spoken and written English and Swedish
• Project Management skills
• Excellent written and verbal communication skills
• Experience of working within a global environment.
• Team working skills, Flexibility, Adaptability, Influencing, Initiative
• Previous experience of working in a Regulatory CMC environment.
Preferable requirements:
• Experience of working with international markets.
• Experience of working in a LEAN environment.
Working with us
We consider ourselves not to be like everyone else, we are proud of our consultants and together we will find the right challenge for you. As a consultant at Experis, we offer you the opportunity to develop your skills in behalf of some of the largest companies in several different industries. We have high expectations of you, but in return we offer excellent development and career opportunities. Here you also get a development plan, so both you and your consultant manager understands what you want to achieve and which skills you want to develop.
Our consultants have a secure job with all that implies in terms of overtime, vacation, pension and insurance under the collective agreement.
Contact person
Apply by register your CV via the link on the right side. Selection is ongoing. For more information about Experis and what we can offer you, please contact Talent Sourcer Jonas Andersson 031-61 72 05 or via email:
jonas.andersson@se.experis.comVaraktighet, arbetstid
100% Enligt överenskommelse
Publiceringsdatum2016-04-01ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2016-04-22
Klicka på denna länk för att göra din ansökanKontaktJonas Andersson 031-617205
FöretagExperis Engineering Huvudkontor
AdressExperis Engineering Huvudkontor
Klarabergsgatan 29
11181 Stockholm
KontorsadressKlarabergsgatan 29
Jobbnummer 2755571
Observera att sista ansökningsdag har passerat.