Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.
Post : Regulatory Affairs Associate II
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.
• 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.
• M.Pharm. or B.Pharm. or Master of Life Sciences
• 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
• 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
• Quality Orientation
• Attention to details
• Team Work
• Specialist Knowledge
Experience : 4-6 years
Qualification : M.Pharm. or B.Pharm. or Master of Life Sciences
Location : Navi Mumbai
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 31st August, 2023