Sofia Rendón Rapp Email & Phone Number

Stockholm, Sverige

Stockholm, Sverige

NDA, USPart of NDA original submission, information requests and approval for the Company’s lead candidate in IgAN (Accelerated approval, Priority Review), including but not limited to being responsible for content overview, collaboration with US agent. Type C meetings and pre-NDA meeting leading up to NDA approval. MAA, EUPart of MAA via the Centralised Procedure (Conditional Marketing Authorisation, Accelerated Assessment) for the Company’s lead candidate in IgAN, including but not limited to being responsible for content overview, collaboration with EU eCTD publisher, Pre-submission meeting, rapporteur meeting leading up to MAA submission. Clarification meeting during MAA. Development projectsResponsible for formulating, leading and driving the RA CMC regulatory strategy for development projects balancing the business benefit with regulatory compliance. Initiate and lead Health Authority submissions, interactions and negotiations within the CMC area as appropriate; set objectives, prepare briefing books, prepare CMC responses, coordinate and plan rehearsals and risk mitigation plans. Make quality regulatory decisions, balancing risks and benefits.Participate in determining the global general RA strategy for development projects balancing the business benefit with regulatory compliance. Participating in the generation of EU Paediatric Investigation Plan (PIP) and US Pediatric Study Plan (PSP), as well as new Orphan Drug Designation (ODD)-applications. Responsible for annual updates to Health Authorities (i.e. SME-, ODD- and DSUR-updates).Represent general RA in the team meetings with clinical CROs during ongoing clinical trials and participate in maintaining the necessary documentation up to date during on-going clinical trials through necessary substantial and/or non-substantial amendments.RA representative during GCP inspections.

Stockholm, Sweden

Pharmaceutical Development Director/Regulatory Affairs CMC Director responsible for formulating, leading and driving the CMC regulatory strategy for development projects balancing the business benefit with regulatory compliance. Initiate and lead Health Authority submissions, interactions and negotiations within the CMC area as appropriate; set objectives, prepared briefing books, prepared CMC responses, coordinated and planned rehearsals and risk mitigation plans, e.g. for EOP2 CMC meeting at FDA and Scientific Advice EMA. Made quality regulatory decisions, balancing risks and benefits.Responsible for the writing of CMC/Quality documentation for clinical trials.Represented the PDM department in the interdisciplinary project team. Participated in the pharmaceutical development and manufacturing activities; e.g. established and maintained a single point of contact with the API supplier, and established and maintained the stability programs.

Stockholm, Stockholm County, Sweden

Pharmaceutical Development Director responsible for the pharmaceutical development, manufacturing and distribution of clinical trial material. Responsible for the writing of CMC/Quality documentation for clinical trials, and maintaining this documentation up to date during on-going clinical trials through necessary substantial and/or non-substantial amendments.Strategic planning of the pharmaceutical development, raw material supply, manufacturing and CMC regulatory pathway from clinical trials up to market launch (both EU and US). Responsible for selecting, and collaborating with, Contract Manufacturing Organisations, including review and approval of Confidential Disclosure Agreements, Master Service Agreements, Manufacturing Agreements and Quality Agreements. Budget responsibility.Responsible for selecting, and collaborating with, expert consultants within e.g. the pharmaceutical development, manufacturing and quality areas, including review and approval of Confidential Disclosure Agreements and Consultancy Agreements.Responsible for two successful technical transfers of different formulations (modified release capsules and lyophilized powder). Part of the Pharmalink Management Team, with daily contact with the other Directors of Clinical Development, Regulatory Affairs and Business Development.

Stockholm, Stockholm County, Sweden

Recruited to work as Pharmaceutical Development Director consultant at Pharmalink AB, Stockholm, Sweden.

Responsible for compiling and reviewing the CMC/Quality documentation for Clinical Trial Applications (IMPD) and for Marketing Authorisation Applications (Module 3 and Module 2 (Quality Overall Summary)). Experience from both EU and US marketing applications. Responsible for updating the in-house system for keeping the regulatory quality documentation up to date with current Production, QA and QC procedures. Delegate to work for the Quality Assurance department with developing and writing the standard operation procedure for the change control and deviation handling within Oasmia. Part of a Quality Steering Committee within Oasmia working with Quality Management items.

Evaluation of the chemical/pharmaceutical part (CTD Module 3) of the documentation referred to and provided with the application for the authorisation of new medicinal products in the EU through the National, Mutual Recognition and Decentralised procedure.As part of the employment at the Medical Products Agency, Sweden:Chemical and Pharmaceutical Expert/Assessor, European Medicines Agency (EMA), London, EnglandEvaluation of the chemical/pharmaceutical part of the documentation referred to and provided with the application for the authorisation of new medicinal products in the European Centralised Procedure.Assessor of the Certification procedure for the Chemical purity and microbiological quality evaluation, EDQM Certification Unit, Strasbourg, FranceEvaluation of the chemical/pharmaceutical part of the documentation referred to and provided with the application for a Certificate of Suitability to the monographs of the European Pharmacopoeia.

Education record

Certificate In Advanced English, English Language And Literature, General

Education record