Regulatory Affairs Associate I

3 days ago

India Teva Full time

Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity
  • To support the UK/IE Regulatory Affairs Team with full administrative support in order to ensure full lifecycle management of Marketing Authorisations (MA's), tracking tools, systems and databases are kept up to date.
  • Assist with all aspects of administrative management and equipment/software inventories as required
How you'll spend your day
  • To work closely with the Line Manager to ensure completion of tasks within agreed timelines
  • Monitor team inboxes where required
  • Administrative support and preparation and management of Product Information in the Teva Document Management System
  • To generate and submit simple variations/label leaflet updates for approved UK/IE products licences.
  • Provision of UK/IE specific information and/or documentation to EU Regulatory Affairs in support of new marketing authorisation applications and variation submissions
  • Ensure that electronic files are up to date and maintained in accordance with Teva procedures
  • Identify and escalate areas of administrative process improvement
  • Accurately updating regulatory information systems following updates
  • Provide support to the UK/IE RA team for all projects which include specific documentation requests
  • Proof reading of mock-ups ensuring compliance at all times
  • Providing ad hoc support to requests from various department functions
  • Administrative support for the cancellation process in accordance to internal processes

Major Job Challenge(s):

  • Meeting specific objectives whilst addressing frequent and often unscheduled issues and changing priorities
  • To regularly discuss administrative workload and ideas for improving processes within the department and to request/offer assistance where needed
  • Working with a wide range of internal and external customers
Your experience and qualifications

Qualification: M. Pharma

Experience: 2 – 4 Years of experience in relevant pharmaceutical field.

Knowledge:

  • Basic understanding of processes and departments within a pharmaceutical company
  • Microsoft Word, Excel and Outlook

Skills

  • Excellent oral and written communication
  • Ability to work under pressure and to tight time deadlines
  • Effective time and organisation management
  • Being able to work under your own Initiative and as part of a team.
  • Computer literacy
Relationships

Internal:

  • All personnel within UK/IE Regulatory Affairs
  • EU Regulatory Affairs
  • Manufacturing, QC testing and QA release sites
  • Supply Chain and EDP
  • Medical Affairs, Medical Information and Pharmacovigilance
  • Commercial, Portfolio and Marketing
  • Artwork Generation Groups
  • Regulatory Information Management Team

External:

  • Business Partners
  • Customers
  • Suppliers
  • MHRA
  • HPRA
Reports To

Associate Director, Senior Manager or Manager Regulatory Affairs

Teva's Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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