This position is responsible for postapproval changes of Marketing Authorisations and product life cyclemanagement.
Tasks
Dutiesinclusive but not limited to thebelow:
* Accountable formanagement of postapproval filings and life cycle maintenancesupplements of Marketing Authorisations like variationsnotifications labelling updates renewals sunset clause etc acrossproduct portfolio.
* Maintenance of MIA and WDAincluding API import registration.
* Filingstrategy and managing submissiontimelines.
* Identifying and remediatingcompliance gaps if any.
* Gather consolidateanalyse documentation and submit regulatoryfilings.
* Coordinate and prepare writtenresponses to requests for information from regulatoryauthorities.
* Monitor status of regulatoryapplications.
* Review and assess the regulatoryimpact of change control/requests for the manufacturing testing andrelease of drug substance and drugproduct.
* Provide product & regulatoryexpertise and clarification on RA requirements for post marketingchanges and new product introduction.
* Provideregulatory support to supply chain commercial teams QP QPPV Quality3rd Party contract management asnecessary.
* Contribute to the creationmaintenance and continuous improvement of Regulatory processespolicies and systems.
* Maintain up to dateknowledge of Regulatory and Quality Management requirements asneeded to support the contract manufacture of current products andthe introduction of new products.
* Build goodworking relationship with CMOs and cross functional teams withinthe organisation.
* Supervise assigned teammembers with respect to management andtraining.
* Shall participate in resourceplanning and recruitment procedure.
* Ensurecompliance with company policies procedures and trainingexpectations.
* Performs other appropriate dutieswherenecessary
Requirements
RequiredSkills:
* understandingof GMP Quality and Regulatoryrequirements.
* communicative and able to workwith a range of stakeholders at all levels both internally andexternally.
* Proficiency in publishing andcompilation of eCTD submissions eCTD validation and viewingtools.
* Maintaining an awareness changingregulatory requirements.
For furtherdetails please contact Tim Barratt on 44(0)