Vacancy for Regulatory Affairs Associate at Teva Pharmaceuticals 2023

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Job Description

Vacancy for Regulatory Affairs Associate at Teva Pharmaceuticals 2023. To perform the necessary regulatory tasks to maintain the existing MRP/DCP/CP licence portfolio in the United Kingdom and Ireland. To follow regulatory guidance and Teva procedures to ensure high quality data and standards are used in support of all regulatory applications to achieve rapid and successful assessment.

Work in conjunction with line manager to give regulatory support to stakeholders and customers, as required. To perform all necessary administrative task in order to ensure full lifecycle management of Marketing Authorisations (MA’s) and to ensure tracking tools, systems and databases are kept up to date.

Organization Teva Pharmaceuticals
Post Name Regulatory Affairs Associate II
Job Location Navi Mumbai
Official Website https://www.teva.com/

Job Title/Position:

Regulatory Affairs Associate II

Job Overview:

Job vacancy for Pharmacy, Life Sciences

Job Location:

Navi Mumbai

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What are the Key Responsibilities?

  • Provide national support for EU variations in line with deadlines set by the requestor and in accordance with in-house standards and current legislation.
  • With support from Line Manager prepare, compile, review and submit appropriate high quality post-approval changes (for example PIQU submissions) and responses to Health Authority questions in accordance with in-house standards and current legislation.
  • Ensure approvals are secured within the stipulated timelines for designated products and projects.
  • Maintain registration documentation and associated electronic databases, in line with Teva’s processes and procedures as outlined in the relevant SOP’s and WI’s.
  • Provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams.
  • Maintain and develop awareness of current/pending regulatory legislation and guidelines.
  • General support activities for the UK/IE RA team, including raising TevaArt projects.
  • Other duties as required at the direction of senior Regulatory Affairs personnel
  • Supporting a large and diverse licence estate.
  • Meeting specific objectives whilst addressing frequent and often unscheduled issues and changing priorities.
  • Developing an understanding of, and familiarity with, the complicated system of regulation and control of medicinal products and adapting to the rapid changes in this area.

What are the Educational Qualification(s) for Regulatory Affairs Associate?

M.Pharm. or B.Pharm. or Master of Life Sciences

What is the Experience Required for this Job?

4-6 years of experience in the Pharmaceutical Industry, ideally within Regulatory Affairs, but experience in R&D, Quality or Operations also taken into consideration

What are the Preferred Skills required for this Job/Position?

  • Desirable to have UK, IE or other EU member state experience and knowledge of regulatory procedures
  • Basic understanding of processes and departments within a pharmaceutical company
  • Excellent English language 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 own Initiative
  • Analytical thinker (data rational)
  • Computer literacy
  • Flexibility
  • Quality Orientation
  • Attention to details
  • Team Work
  • Specialist Knowledge

Related:

Detailed notice

https://careers.teva/job/Navi-Mumbai-Regulatory-Affairs-Associate-II-1435-Indi-400706/1059582400/

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