Core responsibilities include planning and implementing development projects for Marketing Authorisation Applications and Line Extensions aimed at converting a portfolio of specialty unlicensed to licensed medicines. The role requires offering expertise in navigating complex regulatory pathways in order to optimise and expand product portfolio with the most favourable labelling.Collaborating cross-functionally with other business units, I identify regulatory opportunities and plan for resources needed for projects in terms budget and scientific expertise. I am responsible for dossier development including clinical and CMC documentation, overseeing submissions, and managing product life cycles in the UK, EU, and Australia. I actively engage with regulatory authorities for timely approvals and lead Veriton's Regulatory Affairs department, ensuring clear project visibility of status, key issues and challenges within the team.

Part of the Global New Products Introduction Team, providing crucial support to facilitate the identification and evaluation of new product opportunities, and ensure the effective completion of regulatory requirements to secure marketing authorisations.My role involved guiding the Business Development Team, offering regulatory insights on risks, mitigation and due diligence of dossiers. I planned bespoke regulatory strategies, identifying cost, timelines and deliverables that are aligned with the business needs. Undertook timely preparation, review, submission, response to questions and project management of regulatory applications for new products.Additionally, I played a key role in driving vendor services on product development projects, managing external relationships, and collaborating internally including representation at governance committees to communicate risks impacting commercial decision-making. Responsibilities also included direct communication and negotiation with regulatory authorities, facilitating productive dialogues on new product submissions including participating and coordinating Advanz’s scientific advice procedures.

As the main focus of the role, I led the planning, coordination, and preparation of marketing authorisation submissions via National or European procedures (DCP, MRP). My expertise extended to post-authorisation lifecycle management, involving compliance reviews, gap analysis, variations, and renewals.I steered the development and implementation of regulatory strategies for product launches via activating dormant licenses, in-licensing new products, or through own-label supply. As a hands-on contributor, I reviewed (and authored parts of) dossier sections of Modules 1, 2, and 3, maintaining regulatory documentation and serving as a subject matter expert during inspections. Acting as the primary interface with external parties, I collaborated internally with Quality and Commercial teams and played a crucial role in peer reviewing submissions and training and mentoring junior staff.

I specialised in the licensing of parallel-imported medicinal products from within the European Economic Area into the UK. My role involved conducting scientific assessments and approval of product formulation, label, and package leaflet of parallel-imported products. I actively engaged in training and mentoring new Scientific Assessors to achieve accreditation.

I played a pivotal role in generating and updating drug license records, validating submissions for Initial Marketing Authorisation Applications (Nationals, Mutual Recognition, Decentralized procedures), Variations (Type 1B & II), and Changes of Ownership. I contributed to compliance assessments during the national phase of European procedures and was responsible for the assessment and approval of Type IA variations.