Responsibilities:
Product Launches
-Coordinate product launch planning activities between manufacturing, global technical operations groups, quality, supply chain, market level storage & distribution, regulatory affairs, legal and marketing (product management).
-project management plans, production schedules etc.
-Provide direction to new product launch teams regarding European requirements.
-Compile project plans, assigning the various functions with their respective deadlines.
-Conduct regular launch review meetings with each country to provide updates on demand forecasts, regulatory approval status, legal status, storage & distribution, timing of launch readiness and quantity of launch materials.
-Lead meetings with the appropriate contractors to ensure readiness for each product launch.
-Provide technical support on materials, equipment and tooling requirements prior to, and during the launch of new product.
-Provide commercial management with regular updates on status of new product launches, including product availability and regulatory timing expectations.
-Coordinate the preparation of artwork for launch products.
-Provide information needed for the CMC section of the regulatory submission for any new product.
Product Transfers
-Coordinate transfer of an existing contract packaging operation to a new contract packager, in conjunction with storage & distribution model.
-Manage all aspects of transfer activities e.g. packaging, analysis, distribution, regulatory coordination.
-Ensure effective technical transfer of detailed information to the new contractor.
-Provide technical support on materials, equipment and tooling requirements.
-Coordinate the preparation of changed artwork for transferred products.
-Provide information needed for the CMC sections of the regulatory submission for changes to packaging/analytical sites.
Contractor Management
-Ensure that contracts are implemented to cover all necessary commercial, technical, GxP and regulatory requirements.
-Review and approve validation activities related to packaging activities.
-Identify and eliminate any issues within the packaging or testing processes.
-Manage and resolve any GxP / regulatory compliance issues that arise.
-Agree suitable transport and distribution methods.
This is a senior role, a part of senior management and the company is looking for experienced and competent profession who is challenged by new projects and has desire to succeed.
Please send your CV to beata.klecz@secpharma.com or call on 0207 255 6665
