CMC Regulatory Affairs Associate, AstraZeneca
Randstad AB / Administratörsjobb / Nacka
2025-04-01
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Are you passionate about the application of science to deliver life changing medicines?
We are looking for a Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Associate to join AstraZeneca in at Södertälje on a 12-month contract.
Our CMC Regulatory function spans across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.
With our expertise we interpret, anticipate and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies.
We are the bridge between our R&D functions, Operations sites, Quality and Global Supply Teams in helping safe, effective medicines reach the right patient at the right times. We manage the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the commercial lifecycle through to divestment.
What you'll do
Being a CMC RA Associate within the CMC RA Business Development Team means you are responsible for providing support to Chemistry, Manufacturing and Control (CMC) regulatory contributions required for the management of Product Divestments to 3rd Party Customers. You will be art of a dynamic team that works closely with both relevant stakeholders and customers providing regulatory and compliance advice/information to ensure compliant supply of product to customers. The role holder will ensure the application of global CMC regulations and guidance within AstraZeneca to support customer interactions and contribute to updates of processes.
Responsibilities
• Assist in the preparation of regulatory submissions, compilation of submission documentation, and preparation of regulatory components in line with customer requirements/timelines and management of information.
• Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications.
• Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables to facilitate efficient transfer of registered information to the 3rd Party Customer.
• Train, guide and advise others, develop training and user support materials, e.g. job aids, work instructions, training videos, e-learning.
• Business administration of systems, e.g. provision of system access, application of security models and managing change.
• Interact with cross-functional groups and attend team meetings to support submission development and project coordination.
• Assist in the preparation of agendas, presentations, and other supporting materials for various meetings.
• Contribute to the development and improvement of related business processes.
• Ensure the learning from own projects are shared with other colleagues/within the functions.
Essential for the role
• Bachelors degree in Science, Regulatory Sciences, Pharmacy, Pharmaceutical Sciences
• Team working skills
• IT Skills
• Experience in Regulatory Affairs or Quality Assurance
• Fluently spoken and written English and Swedish
Desirable for the role
• Basic Knowledge of the regulatory submissions process
• Understanding of current regulatory CMC requirements
• Basic Understanding of regulations and guidance governing the manufacture of biotechnology products
• Professional Capabilities - Lean Approach
• Quality Risk Management
As a consultant at Randstad Life Sciences, we are your employer, but your daily workplace is at one of our clients. Your consultant manager is always close at hand, both during and between assignments, to help you develop your career in the direction that aligns with your career dreams. As a consultant with us, you receive a competitive salary, benefit set terms according to Swedish collective agreements. At Randstad Life Sciences, we have an offer that gives you the opportunity to develop your skills and/or take extra leave after you have been with us for a while. You will be part of a larger consultant
team within Life Sciences and have the opportunity to expand your network and gain valuable experience from various workplaces.
Submit your application no later than 2025-04-10. Selection and interviews will take place continuously, so submit your application as soon as possible.
Responsibilities
Assist in the preparation of regulatory submissions, compilation of submission documentation.
Upload, retrieval and maintenance of documents for electronic submissions.
Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests.
Interact with cross-functional groups and attend team meetings as to support submission development and project coordination.
Preparation of agendas, presentations, and other supporting materials for various meetings.
Qualifications
Bachelors degree in Science, Regulatory Sciences or Pharmaceutical Sciences.
Basic knowledge of the regulatory submissions process and understanding of current regulatory CMC requirements.
IT skills.
Experience in Regulatory Affairs or Quality Assurance
Fluently spoken and written English and Swedish
About the company
Randstad
At Randstad, we see the possible in people. With business all over Sweden and in all areas of expertise, we help people find work that feels good, where they get the opportunity to develop and realize their true potential.
With close to 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry. Our mission is to become the world's most valued working life partner. By combining our passion for people with the power of today's technology, we support people and organizations in realizing their true potential. We call it Human Forward.
Ersättning Monthly
Så ansöker du Sista dag att ansöka är 2025-04-10
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Randstad AB (org.nr 556242-1718)
Arbetsplats Randstad
Jobbnummer 9259587