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CMC Regulatory Affairs is a global function that manages all Chemistry, Manufacturing and Controls (CMC) regulatory activities across AstraZeneca´s global supply chain. We are looking for CMC Regulatory Affairs Associates to join our CMC team focused on divestment related activities located in Södertälje.

We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to support compliant product supply through partnership with other AZ teams.

The role

As a CMC Regulatory Affairs Associate you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status. You will support externalisation projects where transfer of CMC documentation to external partners is an important and regular task.

You will work with colleagues and other functions within AstraZeneca as well as external partners to obtain information that supports the generation of regulatory CMC documentation.

The role also includes maintenance and change control management of external partners CMC documentation in AstraZeneca systems.

Minimum Requirements - Education and Experience
• Degree in Chemistry or Pharmacy or Chemical Engineering, or equivalent experience
• Fluently spoken and written English and Swedish
• Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
Skills and Capabilities
• Experience from and interest of using Document Management systems
• Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
• Ability to work with short and / or changing timelines
• Able to work collaboratively with customers and colleagues to achieve optimum outcomes
• High level understanding of GMP and working in a regulated environment
• High level understanding of CMC Regulatory
• Excellent written and verbal communication skills
• IT software skills

 

Contact Information
If you have any questions about the position or the recruitment process, please feel free to contact the responsible recruiter:

Ellen Nilsson at [email protected]

For inquiries regarding registration, please contact support at [email protected]

Welcome with your application! 

Keywords
CMC Regulatory Affairs , Astra Zeneca, Södertälje Visa mindre

Modis Life Science is now looking for a consultant for an assignment as Regulatory CMC Associate at AstraZeneca in Södertälje. Note that this is a consultancy assignment and you will be hired by Modis. The assignment will start in beginning of next year and initially run for 12 months. Send your application ASAP. 

About the assignment:

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 looking for Regulatory CMC Associates to our product teams located in Södertälje.

We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to support compliant product supply through partnership with other AZ teams.

The role

As a Regulatory CMC Associate you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status up to approval of CMC documentation supplied by Operations to Global Regulatory Affairs.
You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory CMC documentation.

You may also support externalisation projects and transfer of CMC documentation to external partners.

Minimum Requirements - Education and Experience

• Degree in Chemistry or Pharmacy or Chemical Engineering
• Fluently spoken and written English and Swedish
• Experience in Post Approval Regulatory CMC including CMC documentation authoring
• Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs

Skills and Capabilities

• Able to work collaboratively with customers and colleagues to achieve optimum outcomes
• Knowledge of information and document management technology
• IT software skills
• 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
• Excellent written and verbal communication skills
• Experience from using Document Management systems Visa mindre

Modis Life Science söker nu en Regulatory CMC Associate till ett konsultuppdrag på AstrraZeneca i Södertälje. Uppdraget är planerat att löpa i 12 mån med chans till förlängning. Uppdragstart januari 2020. Skicka din ansökan senast 26 november. 

About the customer

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 the global supply chain.

We are now looking for a Regulatory CMC Associate. This role is available as a temporary contract and will be based in Södertälje, Sweden.

The role

The Regulatory CMC Associate generates CMC documentation presented in the required format to the agreed timetable, for worldwide submissions. You will work with colleagues and other functions to obtain information that supports the generation of regulatory documentation.

• You may also coordinate assembly of submission-ready documents to support lifecycle submissions.
• You will keep business wide electronic systems up to date to be consistent with regulatory submissions and commitments.
• You may also support externalisation projects and transfer of CMC documentation to external partners.
• The role will be based in Södertälje and you will work in a team of 8-10 people.

Minimum Requirements - Education and Experience

• Degree in Chemistry or Pharmacy or Chemical Engineering
• Fluently spoken and written English and Swedish
• Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
• Experience in Post Approval Regulatory CMC including CMC documentation authoring is desirable

Skills and Capabilities

• Able to work collaboratively with customers and colleagues to achieve optimum outcomes
• Knowledge of information and document management technology and electronic/paper publishing software
• IT software skills
• 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
• Excellent written and verbal communication skills Visa mindre