Job title: Regulatory Affairs Associate
Job description: JOB TITLE : REGULATORY AFFAIRS ASSOCIATE
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..
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
The Regulatory Affairs Specialist 1 – Product Regulatory Affairs, assists other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and AstraZeneca standards. The Regulatory Affairs Specialist 1 is an individual contributor who applies regulatory domain knowledge, may work under limited supervision, and participates in continuous improvement of process and tools/systems.
Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements
Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches
Be the interface with Health Authority (HA) and its systems for designated regulatory tasks e.g. management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA Portals
Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation
Provide support across the group for assigned non-drug project roles & responsibilities e.g. act as a designated point of contact or superuser
Provide guidance and knowledge sharing within the RAM skill group
Contribute to process improvement
Minimum Requirements –Education and Experience
Relevant qualification and/or experience in science
Around 2-6 Years’ Relevant experience from biopharmaceutical industry, or other relevant experience
Proficient verbal and written English
Project Management skills
Experience in document management and tracking databases
Some regulatory/medical/technical experience
Knowledge of AZ business and processes
Some knowledge of AZ submissions, compilation, publishing and approval processes, standards, systems and tools
Experience of working with people from locations outside of India, especially Europe and/or USA
Skills and Capabilities
Good written and verbal communication skills
Proficiency with common document management tools
Ability to work independently and as part of a team
Continuous Improvement and knowledge sharing focused
Internal and External Contacts/Customers
Lead RAM and members of the GRET and GRST
Other R&D skill groups, e.g., GRO, GLG, Reg CMC, Operations Regulatory, PS, Reg TA (GRL & Regional Leads)
External collaboration partners
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 add value throughout
SO, WHAT’S NEXT?
Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll 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 15-Mar-2022
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.
Location: Bangalore, Karnataka
Job date: Wed, 16 Mar 2022 06:54:49 GMT
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