International Cmc Regulatory Affairs Associate

7 months ago

Bengaluru Karnataka, India AstraZeneca Full time

**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’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s 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**:

- 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.
- 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
- 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’s 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’S NEXT?**

**WHERE CAN I FIND OUT MORE?**

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.

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