Regulatory Affairs Associate I

7 days ago

Navi Mumbai, India Teva Pharmaceuticals 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 organize and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standard
  • To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory application
  • To ensure high quality documents and standards are used in preparation of all regulatory applications to achieve rapid and successful assessment.
  • To give regulatory support to project teams, stakeholders and other sites, as require
How you’ll spend your day
  • Prepare, compile, review and submit high quality submissions for all required post-approval activities in accordance with EU legislation and in-house standards.
  • Responsibility for MA compliance with both legislation and business needs.
  • Prioritize, plan and monitor submissions for allocated procedures while documenting and informing involved parties of progress.
  • Ensure approvals are secured within the stipulated timelines for designated projects.
  • Maintain registration documentation and associated electronic databases, in line with in-house procedures.
  • Provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams.
  • Communicate with other Teva departments across Europe and European Agencies regarding proposed and pending submissions.
  • Maintain and develop awareness of current/pending regulatory legislation and guidelines.
  • Fulfilling other allocated department duties and ad-hoc needs at the direction of Senior Regulatory Affairs personnel.
  • Awareness of current/pending regulatory legislation and guidelines.
Your experience and qualifications
  • Degree/ Master in Pharmacy or Master in Science/ Life science
  • Relevant years of experience required: 2 to 3 years in Regulatory affairs with EU post approval
  • Overall Pharma Industry experience: 2 to 3 years
  • Desirable to have EU member state experience and knowledge of European regulatory procedures.
Knowledge and Skills required
  • Understanding of processes and departments within a pharmaceutical company.
  • Good oral and written communication
  • Ability to work under pressure and to tight time deadlines
  • Effective time and organization management
  • Initiative
  • Analytical (Data and Documentation)
  • Computer literacy
  • Teamwork and collaboration
  • Attention to detail
  • Planning and Organization
Reports To

Manager Regulatory Affairs

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