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Associate – II | Product Regulatory Affairs | Astra Zeneca Pharma | Bangalore

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AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.

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You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.

Position: Associate – II, Product Regulatory Affairs

Location: Bangalore, Karnataka, India

Job Description:

The Position:

  • The Associate II – Product Regulatory Affairs, assists other members of Regulatory Project Management (RPM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licenses and applications in accordance with agreed regulatory strategy and AstraZeneca standards.
  • The Associate II 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 RPM skill group
  • Contribute to process improvement

Skills and Capabilities

  • Good written and verbal communication skills
  • Cultural awareness
  • Proficiency with common document management tools
  • Ability to work independently and as part of a team
  • Continuous Improvement and knowledge sharing focused
  • 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 the USA
  • Proficient verbal and written English
  • Project Management skills
  • Experience in document management and tracking databases

Qualification: Appropriately Qualified

Experience: Around 2-6 Years’ Relevant experience from the Biopharmaceutical industry, or other relevant experience

Salary: Negotiable

Contact Details:

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