Regulatory Affairs Specialist I

by

Job title: Regulatory Affairs Specialist I

Company: AstraZeneca

Job description: JOB TITLE: Regulatory Affairs Specialist I
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
The Regulatory Affairs Specialist 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 Affairs Specialist I is an individual contributor who applies regulatory domain knowledge, may work under limited supervision, and participates in continuous improvement of process and tools/systems.
Accountabilities/Responsibilities:

  • 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
  • Minimum of 2 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 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

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?
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.

Date Posted 03-Nov-2022

Closing Date

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.

Expected salary:

Location: Bangalore, Karnataka

Job date: Sat, 05 Nov 2022 05:51:56 GMT

Apply for the job now!