Job Description
Overall Job Purpose:
• To organise and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standards.
• To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory applications.
• 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 required
Overall Job Purpose:
• To organise and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standards.
• To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory applications.
• 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 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.
• 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.Pharm, Diploma (RA)
Location : Mumbai
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 15th March, 2019
Qualification : M.Pharm, Diploma (RA)
Location : Mumbai
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 15th March, 2019
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