CMC Regulatory Affairs Associate

PharmaRelations

Sweden - Södertälje

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On behalf of AstraZeneca we are looking for a Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Associate to join at Södertälje (SE) on a 12-month contract. This is a consultant assignment and you will be employed by PharmaRelations.

Chemistry, Manufacturing, and Controls (CMC)
Our Chemistry, Manufacturing, and Controls (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. Part of a dynamic team that works closely with both relevant AZ stakeholders and Customers providing regulatory and compliance advice/information as appropriate to ensure compliant supply of product to Customers. The role holder will ensure, where appropriate, the application of global CMC regulations and guidance within AstraZeneca to support Customer interactions and contribute to updates of processes as appropriate.

Responsibilities:
· As necessary, 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.

· As necessary, 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.

· The role holder will 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 as necessary 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:
· Foundational / Associate degree in Regulatory Sciences, Pharmacy, or Pharmaceutical Sciences

· Team working skills

· IT Skills

· Experience in Regulatory Affairs or Quality Assurance.

Desirable for the role:
· Bachelors degree in Science, Regulatory Sciences, Pharmacy, Pharmaceutical Sciences

· 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

Apply below as soon as possible as we are already interviewing candidates. For more information contact Shiva Hobbi Nowzari, [email protected]. or Viktoria Lindström, [email protected]. Note that due to GDPR we cannot accept any applications or CVs via e-mail.