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Regional Regulatory Hub Strategy Senior Associate (AfME)
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Regional Regulatory ....
drjobs Regional Regulatory Hub Strategy Senior Associate (AfME) العربية

Regional Regulatory Hub Strategy Senior Associate (AfME)

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1 Vacancy
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Jobs by Experience

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0 - 3 years

Job Location

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Amman - Jordan

Monthly Salary

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JOD 123 - 123

Nationality

Any Nationality

Gender

N/A

Vacancy

1 Vacancy

Job Description

Req ID : 1143868
  • Maintain effective regional relationship with stakeholders to ensure communication /clarity of regulatory strategy and timelines.
  • Apply regulatory expertise for assigned Products/countries to enable preparation of high quality documentation and assure compliance with departmental procedures.
  • Assist and liaise with GCMC, global/product strategists, PGS, Submissions Management, In-Country Regulatory , ILG, ALIM, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and BoH requirements are met, ensuring a submission ready dossier. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations. Ensure a submission planning and forecasting tool is utilized to update timelines.
  • Assist and support all product lifecycle regulatory work, and liaise with GCMC, Submissions Management, Cluster/Market, and any other key stakeholders.
  • dispatch dossiers to In-Country Regulatory .
  • Regularly follow up with In-Country Regulatory Team on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.

Employment Type

Full Time

Company Industry

Pharma / Biotech / Clinical Research

Department / Functional Area

Administration

Key Skills

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