CMC Regulatory Affairs Associate to AstraZeneca

We are currently seeking 2 self-motivated CMC Regulatory Affairs Associates to be part of AstraZeneca in Södertälje!

Are you passionate about the application of science to deliver life changing medicines? AstraZeneca in Södertälje is now looking for 2 CMC Regulatory Affairs Associates to join the team. Don´t miss out on this opportunity – apply today!

Purpose, Offer and Benefits

This is a consulting assignment set to begin in February with a duration until December 20th. You will be employed by TNG during the assignment period.

At AstraZeneca you will join a place built on innovation and creativity. Where different views and perspectives are encouraged and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

Your Responsibilities

As a CMC RA Associate you are responsible for providing support in the collection, evaluation, preparation, and assembly of Chemistry, Manufacturing and Control (CMC) regulatory contributions required for clinical, marketing or post-approval submissions. As part of a dynamic team that works closely with relevant product and project teams providing regulatory and compliance advice as appropriate. The role holder will ensure the application of global CMC regulations and guidance within AstraZeneca and contribute to updates of policy and processes as appropriate.

You will:

• Assist in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components.
• Support delivery of submission ready packages to agreed timelines and management of information required.
• Be 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.
• Develop research skills relevant information, regulations, and guidance from different regulatory agencies.
• Assist in the preparation of agendas, presentations, and other supporting materials for various meetings.
• Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.

The Bigger Picture

Our Chemistry, Manufacturing, and Controls (CMC) Regulatory functions span 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 handle the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products´ throughout the commercial lifecycle; including marketing Authoring Applications (MAAs) and all post approval activities maximising the value of business critical Supply Chain changes to the AZ organisation by supplying the regulatory context, intelligence and guidance required to advise the development of robust plans for change initiatives.

Our Expectations

• University degree in chemistry, pharmacy, or chemical engineering or equivalent experience
• Experience in CMC Regulatory Affairs
• Proficiency in both English and Swedish is required.
• Background in Pharmaceutical Production, Quality Assurance, Quality Control, or Product Maintenance is advantageous.
• Team working skills
• IT Skills
• Self-motivated