Regulatory Affairs Senior Specialist - Taguig
4 linggo ang nakalipas
Job summary
The Regulatory Affairs Senior Specialist – Partnered Product manages regulatory quality compliance aspects of partnering activities ensuring smooth transitions and compliance for in-licensed out-licensed products.Responsibilities
- Evaluate regulatory dossiers of in-licensed products for compliance market readiness
- Conduct risk assessments for out-licensed products collaboration with partners
- Support registration of in-licensed products by reviewing compiling required documentation Prepare regulatory packages for out-licensed products meet partner local requirements Act as primary regulatory contact for in-licensing out-licensing partners Ensure timely updates compliance contractual obligations related to regulatory matters Monitor regulatory landscapes key markets support licensing decisions Provide input on regulatory feasibility timelines during partnership negotiations Manage lifecycle activities like renewals variations periodic reporting licensed products Ensure alignment partner authority requirements partnered products Maintain detailed records in-licensing out-licensing regulatory agreements Prepare clear concise reports internal partner updates Collaborate partners ensure compliance Good Manufacturing Practices GMP quality standards Review assess quality agreements in-licensing out-licensing partners Support deviation management change controls corrective actions related partnered products Ensure quality compliance product transfers batch releases post-market surveillance Review marketing materials ensure compliance regulatory global guidelines Ensure promotional content aligns local partner market regulations Collaborate internal teams partners address regulatory global concerns advertising promotional strategies Monitor post-market promotional activities comply with regulated standards
Paglalarawan ng trabaho
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