Lead Consultant - Regulatory Affairs

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Invitingapplicationsforthe role of Lead Consultant - Regulatoryaffairs.

We are seeking a supportforclient in theirrequestedrequirementforregulatorysubmissionsthatmayhaveimpactonregistrationsofsmallmolecules, biologics and combinationproducts.

Responsibilities

Supportthrough a numberofregulatory functions specifictopost-approval, lifecyclemanagementcapacitieswhichincludes -

• Provide scientific inputs and actively involved in RA CMC strategic discussions

• Monitor assumptions, risks and dependencies

Manage and oversee regulatory post approval Chemistry, Manufacturing and Controls (CMC) changes involving deliverables such as:

• Provide of regulatory evaluation of change control (affected countries, data/documentation requirements per country, change category per country and regulatory procedure per country) and regulatory strategy

• Provide tracking list and review documentation

• Dispatch final documentation package to Local Regulatory Affairs (LRA) in affected countries

• Monitor timely submission and approval in affected countries

• Manage and coordinate responses to health authority questions

• Overall planning of all CMC regulatory changes per product together with relevant interfaces

• Represent G CMC RA in cross-functional teams

• Experience working for major regulated markets - EU (different types of variations, work sharing/ super grouping), US, Japan, China

Manage and oversee support for renewals and post approval CMC commitment involving deliverables such as:

• Provide regulatory requirements and regulatory strategy to relevant interfaces

• Review documentation

• Dispatch final documentation package to Regional Regulatory Lead (RRL) for further distribution to LRAs

• Manage and coordinate responses to health authority questions

• Overall planning of all renewals per product together with relevant interfaces

• Represent G CMC RA in cross-functional teams

CMC management :

• Authoring of Dossier sections - Module 2 and Module 3 - DS and DP according to the relevant regulatory requirements and GMP rules.

• Compilation of CMC documents for MAA, renewals, variations, commitments, Response to health authority queries

• Interaction and cooperation with experts from the relevant departments and CMOs (contract manufacturers and contract laboratories), also in non-European countries, to compile the information and data required for Module 3.2.P.
  Interaction with competent authorities in the context of ASMF/DMF and CEP activities.

General tasks:

• Support and coordination of audit and inspection related activities

• Maintain up-to-date knowledge of regulatory requirements and guidelines

• Provide regular progress reports and updates

• Acting and living in client processes, and systems

Experience:

Relevant experience in CMC tasks and related aspects.

Experience working on biological products required

Qualificationsweseek in you!

MinimumQualifications

AtleastBachelor%27s degree required in for Pharmaceutical: science, engineering, or related field (advanced degree preferred).