• Compile and assess submission packages for both human and veterinary products related to CMC lifecycle, Post Authorisation Procedures/ Maintenance incl. Renewal, Submission of variations based on EC 1234/2008
• Conduct compliance check on product dossiers (i.e. approved by Health Authorities vs applied/implemented at company production facilities)
• Initiate, evaluate and execute Change Request related to Labelling Quality amendments e.g. via EQMS or Trackwise
• Coordinate, Prepare, Submit and Obtain Marketing Authorisation Approval (MAA) for European Marketing Authorisation Procedures (i.e. National and MRP/DCP/CP procedures)
• Manage and realize annual submission plan of regulatory applications across Product Portfolio (e.g. women health, osteoporosis, flu vaccine products)
• Write and Evaluate CMC documentation (i.e. CTD Module 2.3 and Module 3 such as for Hormone, Flu vaccine and biosimilar products and NTA Module Part II for veterinary medicinal products)
• Secure agency communications and targeted correspondences for dossier documentations relating to quality (CMC) fields of Regulatory applications and submissions
• Prepare meeting materials/ briefing packages to and act as single contact to Health Authorities for regulatory applications (e.g. EMA, BfArM, PEI, BVL, MEB, FAGG, Swissmedic etc..)
• Submit regulatory applications via CESP and e-Portal to Health Authorities including EMA
• Work with Electronic Database management system (e.g. Veeva Vault, FirstDoc)
• Publish and validate eCTD submission package for regulatory applications (e.g. DocuBridge, eCTD Office)
• Prepare and compile application dossiers for International Marketing Authorisations in developing countries outside Europe (e.g. Singapore, Thailand, Brazil, South Africa)
• Arrange CPP (certificates for medicinal products) application
• Provide Interim Management in CMC Regulatory Affairs (e.g. change controls evaluation, documents checklist for regulatory submissions, tracking upcoming submissions and meeting the timelines)

• eCTD/ NeeS submissions of Module 1, 2 and 3 (CMC)
• Dossier maintenance (i.e. Renewals and Variations)

• Installed the new organization of Campina Innovation (of 38 FTE?s) connecting local regional R&D satellite teams to increase the R&D capability for the division of the white dairy products in Europe

Various roles as:

• Research Fellow
• Food Product Developer
• Project Manager and New Business Developer in Developing Countries (e.g. Indonesia, India, Kenya and Brazil)