Regulatory Affairs Associate II
JOB TITLE: Regulatory Affairs Associate II
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
Description: The Regulatory Affairs Associate II is a senior specialist which 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 Associate II is an individual contributor who works independently, applies regulatory domain knowledge and leads continuous improvement of processes 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.
Contribute to EU-CP Linguistic review
Provide guidance and knowledge sharing within the RAM skill group
Contribute to process improvement
Support GRET RAM and LRPM on any operational tasks
Audit Support and Tender Support to GRET.
Support proofreading request via TVT for Standard export pack labels etc.
Minimum Requirements –Education and Experience
Relevant qualification and/or experience in science
Minimum 4 years of Relevant experience from biopharmaceutical industry, or other relevant experience
Proficient verbal and written English
Project Management skills
Experience in document management and tracking databases Preferred Experience
Some regulatory/medical/technical experience
Knowledge of AZ business and processes
Some knowledge of AZ submission, 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
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
Internal and External Contacts/Customers
Lead RPM and members of the GRET and GRST
Other R&D skill groups, e.g., GRO, GLG, Reg CMC, Operations regulatory, PS, Regulatory Central, GRL & Regional Leads
External collaboration partners
WHY JOIN US?
We’re a network of high-reaching self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions.
We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it’s because we make a significant impact. Everything we do matters.
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 https://www.linkedin.com/company/1603/
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.
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.