Teva Regulatory Affairs Associate 

India, Maharashtra, Navi Mumbai 

183421737

• 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

• 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.
• Prioritise, 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 regulatory legislation and guidelines

Required Degree: Master in Pharmacy or Master in science/life sciences

Experience:

• Total years of experience required for the role: 2 to 3 years in Post approval Regulatory affairs
• Overall Pharma industry experience: 2 to 3 years
• Desirable to have EU experience and knowledge of European regulatory procedures.

• Desirable to have EU member state experience and knowledge of European regulatory procedures.
• Understanding of processes and departments within a pharmaceutical company.
• Excellent oral and written communication
• Ability to work under pressure and to tight time deadlines
• Effective time and organisation management
• Negotiation
• Initiative
• Analytical (Data and Documentation)
• Computer literacy
• Teamwork and collaboration
• Attention to detail
• Planning and Organisation