Priya Pathak Email and Phone Number

Responsibility for the regional regulatory strategy for products within my portfolio, working with the country affiliates to ensure that performance is maximized across the region. Using knowledge and expertise of the region to provide direction on the preparation of country-specific NDA’s and post-marketing variations prioritising global labeling updates as well as CMC variations and generating responses to agency questions accordingly.

Responsible for all regulatory, pharmacovigilance and quality assurance-related affairs and communications to the Ministry of Health and sales and marketing functions for the Singapore affiliate. Liaising with regional regulatory colleagues to file new product registrations as well as ongoing renewals, variations and maintenance of registered products. Providing regulatory expertise and support to commercial counterparts.

Provide considered regulatory support, advice, leadership and expertise to brand teams and to regulatory and other cross functional groups within GSK. Training and developing more junior staff in the department. Driving the preparation and compilation of submissions to the MHRA in relation to the granting of marketing authorisations, variations to marketing authorisations, clinical trial submissions and amendments to the same. Providing regulatory input into promotional campaigns, building and maintaining cross-functional relationships, writing and simplifying SOP's and guidance documents and keeping abreast of national regulatory changes.

Providing regulatory advice and support to the UK, Ireland and Malta Abbott affiliates. Acting as a deputy to the Regulatory Manager as required and to provide line management for direct reports and supervision of staff. Leading on the regulatory authority approval process for new clinical trials and amendments to such trials undertaken in the UK, Ireland and Malta. Obtaining regulatory authority approval for marketing authorisations for new pharmaceutical products in the UK, Ireland and Malta.Responsible for maintaining all existing pharmaceutical product marketing authorisations and gaining regulatory authority approval for the amendments of these authorisations as required. Reviewing and working with brand and medical teams on packaging texts, labelling and promotional materials to ensure full product benefits are detailed and that materials are patient friendly, compliant with legislation and the code of practice. Representing Regulatory Affairs in cross functional New Process Introduction Teams and Core Therapeutic Teams.

Driving the acquisition of regulatory approvals through National Marketing Authorisation Applications and Mutual Recognition Procedures throughout Europe. Advising and providing regulatory support to in-house development teams and principal customers. Submission of updated dossiers to Reference Member States to initiate Mutual Recognition Procedures within targeted time-lines. Advising and liaising with the in-house development team to prepare and submit responses to questions from National Authorities to obtain Marketing Authorisations within tight deadlines. Provision of quality advice on all regulatory matters to internal and external customers. Submission of mutual recognition variations and applications for manufacturing licences to ensure product compliance with current guidelines and the requirements of Heads of Agencies.

Expediting regulatory approvals for defined product responsibilities throughout Europe and provide regulatory support to project teams and key customers. Preparing, compiling, reviewing and submitting high quality regulatory dossiers in accordance with the relevant requirements and legislation to tight deadlines. Co-ordinating the preparation and conducting the review of responses to questions raised by regulatory authorities. Providing regulatory advice and support to project teams for defined product responsibilities and key customers. Assistance with planning and co-ordination of mutual recognition procedures and assistance with due-diligence reviews of MAA’s in compliance with EU legislation. Maintenance of existing licences within the EU to ensure their compliance with current guidelines and national requirements.