Introduction to Role:
Join our International Regulatory Affairs Management (RAM) team as a Regulatory Affairs Associate I. This role is an exciting opportunity to contribute to the development and approval of life-changing medicines for patients in international markets. As a Regulatory Affairs Associate , you will assist in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and AstraZeneca standards. This role is perfect for an individual who thrives in a team environment, applies regulatory knowledge, and is eager to participate in continuous improvement of processes and tools/systems.
Accountabilities:
As a Regulatory Affairs Associate , you will be responsible for document management, including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements. You will maintain documentation & records management in Veeva RIM system in accordance with defined standards & process. You will also be responsible for planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches. Additionally, you will be the interface with Health Authority (HA) and its systems for designated regulatory tasks.
Essential Skills/Experience:
– Relevant qualification and/or experience in science
– Regulatory experience from biopharmaceutical industry, or other relevant experience
– Some regulatory/medical/technical experience
– Knowledge of AZ business and processes
– Knowledge of AZ submissions, compilation, publishing and approval processes, standards, systems and tools
– Good written and verbal communication skills
– Experience of working with people from locations outside of India, especially from International Regions
– Good commercial and product awareness
– Good Communication and influencing skills
– Good IT/IS skills
– Project planning and organisational skills – Focus on delivery and results
– Flexibility and adaptability
– Interpersonal and networking skills
– Independent and Team working
– Proactivity
– Problem solving
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we are committed to turning our drug development strategies into reality. We 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. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what’s next. We are striving for technology adoption and automation to drive efficiencies and new innovations.
Are you ready to join a team with deep specialist knowledge and Regulatory expertise? Are you confident in stepping up and taking accountability? If so, apply now to join our efficient and nimble team in Biopharmaceuticals R&D!
- Job Title: Regulatory Affairs Associate I
- Career Level – C
- Location: India – Bangalore
- Job ID: R-196194