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 I - Executive
Job Description
Overall Job Purpose:
1) To organise and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standards.
2) To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory applications.
3) To ensure high quality documents and standards are used in preparation of all regulatory applications to achieve rapid and successful assessment.
4) To give regulatory support to project teams, stakeholders and other sites, as required.
Main Responsibilities:
• 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.
• 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.
• Prioritise, plan and monitor submissions for allocated procedures while documenting and informing involved parties of progress.
• 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.
Additional Information
Qualification : M.Sc, M.Pharm
Location : Navi Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 20th July, 2019
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