Job Description

Job Title - Associate - International CMC Regulatory Affairs

Career Level - C

Lead the way for a new breed of solutions-oriented Regulators

Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development

Be part of the team where you are empowered to follow the science

Be part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals.

ABOUT ASTRAZENECA

At AstraZeneca we\xe2\x80\x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There\xe2\x80\x99s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development

ABOUT THE TEAM

We are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients.

ABOUT THE ROLE

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.

What you will do :

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

Assist in the preparation of international regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components.

Ensure that publishing tools are in place and to perform publishing of the CMC sections in a timely manner.

Support and delivery of submission ready packages to agreed timelines and management of information required.

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.

The role holder will train, guide and advise others, develop training and user support materials, e.g. job aids, training videos, e-learning

Writing scripts and participating in system testing in support of system releases

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.

Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.

Ensure the learning from own projects are shared with other colleagues/within the functions.

Essential Requirements

Foundational / Associate degree in Science, Regulatory Sciences or Pharmacy

Team working skills

IT Skills

Self-motivated

Professional capabilities: Regulatory knowledge.

WHY JOIN US?

We believe there\xe2\x80\x99s always a better way of doing things. Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things and sharing new proposals.

Our advanced approach to Regulatory means we are leading the field. We get to work closely with drug development to influence early on and continue to make valuable contributions throughout.

SO, WHAT\xe2\x80\x99S NEXT?

Are you already envisioning yourself joining our team? Good, because we\xe2\x80\x99d love to hear from you! Click the link to apply and we\xe2\x80\x99ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

Date Posted 25-Jan-2024

Closing Date 31-Jan-2024

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca