Regulatory Affairs Associate II

2 days ago

India Teva Full time ₹ 50,00,000 - ₹ 80,00,000 per year

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 perform the necessary regulatory tasks to help obtain new Marketing Authorisations and maintain the existing licence portfolio in the UK/IE.
  • 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 project teams, stakeholders and customers, as required.
How you'll spend your day
  • With support from Line Manager prepare, compile, review and submit appropriate high quality post-approval changes (variations, renewals, PIQU submissions) and responses to Health Authority questions in accordance with in-house standards and current legislation.
  • Provide administrative support for new Marketing Authorisation Applications for UK (GB/NI)
  • Provide national support for EU variations / new marketing applications in line with deadlines set by the requestor and 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.
  • To work closely with Line Manager to prioritise, plan and monitor allocated projects against defined timelines.
  • Maintain and develop awareness of current/pending regulatory legislation and guidelines
  • General support activities for the UK/IERA team including support for Teva's finance system (raising PO's and approving invoices)
  • Other duties as required at the direction of senior Regulatory Affairs personnel.

Major Job Challenge(s):

  • 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
Your experience and qualifications

Qualifications and Experience:

  • M. Pharma with 4 – 7 Years of experience in relevant pharmaceutical field.

Knowledge:

  • 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

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
Relationships

Internal:

  • All personnel within UK/IE Regulatory Affairs
  • EU Regulatory Affairs
  • Manufacturing, Packaging, QC testing and QA release sites
  • Portfolio and Project Management
  • Business Development
  • Product marketing and management
  • Supply Chain and EPD
  • Medical Affairs, Medical Information and Pharmacovigilance
  • Customer Sales Marketing
  • Procurement
  • Artwork Generation Groups

External:

  • MHRA
  • HPRA
  • Customers
  • Suppliers
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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