Regulatory CMC Manager to AstraZeneca in Södertälje
Alten Sverige AB / Sjukhusteknikerjobb / Stockholm
Observera att sista ansökningsdag har passerat.
Visa alla sjukhusteknikerjobb i Stockholm,
Solna,
Lidingö,
Sundbyberg,
Danderyd eller i
hela Sverige Visa alla jobb hos Alten Sverige AB i Stockholm,
Upplands Väsby,
Södertälje,
Uppsala,
Östhammar eller i
hela Sverige ALTEN Pharma in Stockholm is looking for a competent and driven Regulatory CMC Manager for a consultancy assignment at AstraZeneca in Södertälje.
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 are 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.
CMC Regulatory Compliance & Stability is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain.
The role:
The role of Regulatory CMC Manager is focused on Post Approval Regulatory Chemistry, Manufacturing and Control (CMC) strategy and delivery within our CMC Regulatory Compliance Department.
Main Purpose of the role:
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.
Education and Experience
Essential requirements:
• 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.
• IT skills and/or knowledge of information and document management technology and electronic/paper publishing software
About ALTEN:
For over 20 years, ALTEN has developed its business by keeping to the core values ??that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Karin Söderlind, Business Manager Pharma, at
karin.soderlind@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-03-27ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-04-12
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4048211
Observera att sista ansökningsdag har passerat.