AddressJob Title: Regulatory Affairs Associate I (International Regulatory Affairs)
Career Level - C
Introduction to Role:
Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business to accelerate Regulatory approvals for new medicines in International markets as efficiently and effectively as possible so that no patient waits.
A fantastic permanent opportunity has now arisen for a Regulatory Affairs Associate I to join our International Regulatory Affairs Management (RAM) team. The Regulatory Affairs Associate I 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 AffairsAssociate I is an individual contributor and active team contributor who applies regulatory knowledge, may work under limited supervision, and participates in continuous improvement of process and tools/systems.
Accountabilities:
Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements
Maintain documentation & records management in Veeva RIM system in accordance with defined standards & process and as requested by RAMs eg. support with Submission Ready standards/Housestyle skills & QA checks, specific authoring tasks
Input regulatory knowledge, intelligence & information into relevant systems and databases maintaining data accuracy and up to date information for the group and relevant databases and platforms.
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. CPP ordering. 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, requesting authentication of documents, 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
Essential Skills/Experience:
MinimumRequirements
Relevant qualification/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
Skills & Capabilities
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
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, Reg TA (GRL & Regional Leads)
Marketing Companies
Health Authorities
External collaboration partners
AstraZeneca Legal
Reporting Relationship
Direct Reports - None
Indirect Reports -None
When we put unexpected teams in the same room, we unleash bold thinking with the power to 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.
Why AstraZeneca?
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 be part of the solution, involved in key discussions, acting as both a drug developer and Regulator? Are you curious by nature, ready to dig into challenges to get to the core of a solution? If so, we would love to hear from you!
Apply now to join our efficient and nimble team!
