Regulatory Affairs Associate I
1 week ago
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 requireHow 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-
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