• Drug listing of commercial pharmaceutical products imported to/within the US, with the FDA.• Renewal of Drug Establishment Registrations and Food Facility Registrations with the FDA. • Renewal of all site licenses (including manufacturing licenses) with the relevant authorities.• Liaise with all Catalent facilities to ensure that the documents held in the Site Profile System Master Library are current.• Provide training (if necessary) in the use of Site Profile System Master Library.• Assist with appropriate updates to MHRA, FDA etc after mergers, acquisitions or divestments.• Contribute (from regulatory perspective) to company-wide projects to ensure continued licenses and permits are in place to sustain manufacturing capacity and adherence to customer requirements.• Aware of current regulations within the pharmaceutical industry.• Variation submission of the Manufacturing Licenses to the MHRA.• Experience in writing and submission of PAS variations in the eCTD format to the FDA.

• Compilation and preparation of CMC, (Module 2 and 3) in the NeeS format including compilation of an original drug master file from development and pilot batch data for a new API.• Preparation and submissions of Type IAIN MRP Marketing Authorisation Variations applications in NeeS format to 16 European Health Authorities, including MHRA electronic portal submissions and dispatch by CD, hard copy and Eudralink. Interaction with local consultants in the CMS. • Assembly and dispatch of market authorisation application via a DCP application to a number of European Health Authorities.• Preparation of API documents for a customer’s MA application to a non-EU country (Russia) including the notarisation and apostillation of documents. • Preparation and submission of response to questions on a DMF following submission to the Croatian Health Authority.• Preparation and submission of response to MA variations questions to European Health Authority.• Routine monitoring and reporting of regulatory legislation and guideline changes.• Preparation and issue of CEP Letters of Authorisation to customers for submission to Health Authorities (Middle East).• Knowledge of submissions using MHRA Portal and searches using (RAMA database) for granted MA details.• Performed gap analyses identifying any discrepancies between registered information and the processes and documentation used during manufacturing including compliance review of API’s.

• Actively involved in the design, development and optimisation of chemical processes which are efficient, robust, reproducible, cost effective, and suitable for manufacturing on a multi-kg scale.• Supervised production staff manufacturing within a specified timescale. • Worked in close conjunction with QA and QC department to oversee manufacturing in compliance with cGMP regulations.• Generated cleaning protocols for decontamination of processing equipment. Carried out validations on process equipment (IQ, OQ and PQ)• Prepared Batch Manufacturing Records, Change Controls, Planned, Unplanned Deviations and wrote Standard Operating Procedures (SOP’s).• Carried out CAPA investigations with non-compliance entities as part of QMS.• Knowledge of relevant ICH Quality guidelines.• Liaised closely with regulatory affairs department on issues relating to DMF preparation.• Prepared and responded to audit questions raised by MHRA, FDA, as well as any internal and customer audits. • Trained in effective man management.

• Researched potential routes which did not infringe on any patents, through comprehensive literature searching.• Preparation of COSHH and risk assessments for all chemicals and solvents to be used in processing.• Early stage investigation of synthetic routes for scale up. • Successfully transferred technology from laboratory scale to full production scale.• Experienced in manipulating air sensitive compounds.• Knowledge and use of preparative-HPLC, HPLC, LC-MS, IR, DSC and NMR analyses.• Isolation of chemical intermediates and impurities by flash chromatography, automated chromatography system (Biotage) and recrystalisation techniques and identification of chemical structures by spectroscopic methods.

Responsible for stability testing of pre-clinical drugs. Duties included using HPLC, UV, TLC and other analytical techniques. Operated Laboratory Information and Management Systems (LIMS). Organisation and presentation of technical reports.