Alison Malcolm Email & Phone Number

Galashiels, Selkirkshire, Gb

Developing global regulatory strategy for range of products in development

London, United Kingdom, Gb

Orchard Therapeutics is developing hematopoietic stem cell (HSC) gene therapy products, focussing on the treatment of rare, inherited disorders.Global regulatory specialist for clinical trials across the early-stage clinical portfolioLead a cross-functional team responsible for the implementation of the Clinical Trials Regulation (CTR) into company processesRepresented the Regulatory function at cross functional submission and study management team meetings ensuring optimal start-up and maintenance of clinical trialsLiaised with, and performed oversight of, CROs contracted to Orchard projectsRegulatory representative for GCP inspection readiness activities

Regulatory affairs and product development support for variety of product types and therapeutic areasFull lifecycle experience from early development through to post-approval maintenanceCTA applications, Phase 1 to 3 studiesGMO applications Centralised Procedure - MAA and post authorisation activitiesPaediatric Investigation Plans – applications, waivers and modificationsScientific Advice support – requesting meetings, preparation of briefing packagesOrphan designation applications & maintenance (including use of EMA IRIS system)Linguistic reviewsPIL user tests – write protocols and prepare reports

Diamond BioPharm is a regulatory consultancy providing services to the biotech and pharmaceutical industries.

Canonsburg, Pennsylvania, Us

Full lifecycle activities for generic products approved by the Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP) or national authorisation.within the Europe, Middle East and Africa (EMEA) region, Prepared and submitted dossiers to support Marketing Authorisation Applications (MAA) for new products. Defined strategy for submission of new products.Ensured pre-launch activities completed to allow launch of new products as scheduled.Carried out maintenance activities for existing products, submitting variations to register safety, CMC, labelling or administrative changes, renewal applications and PSUR submissions.Assumed role of UK affiliate, supporting all UK national licences and national phases of DCP/MRP activities, including PIQ unit submissions to maintain product information and artwork in accordance with MHRA guidelines.

Thousand Oaks, Ca, Us

Employed in Oncology Therapeutic Area supporting Phase 2 and Phase 3 clinical studies within international region, specifically EU, Asia Pacific and Latin America.Preparation and submission of regulatory documentation to support clinical trial applications (CTA), amendments, urgent safety measures and end of trial notifications.Detailed understanding of EU Clinical Trials Directive.Experience in use of Voluntary Harmonisation Procedure (VHP)Review and approval of clinical trial labelling.Preparation of regulatory landscape documents on range of tumour types.Tracking of all submissions and approvals, ensuring inspection readiness at all times.

Brentford, Middlesex, Gb

Development of cell-based functional assays for range of recombinant protein targets.Generation of screening data to support hit identification and lead optimisation programs.Line management of teams of scientists.Program leadership of multi-disciplinary teams.

Brentford, Middlesex, Gb