Arpit Patel Email & Phone Number

United Kingdom

Skillman, New Jersey, Us

As Global Regulatory Affairs CMC, I am responsible for leading CMC team and strategies for Digestive Health (DH), Eye Care (EC), Allergy and Anti-Infectives. As a CMC lead for these therapy areas, I participate in following activities and deliverables:· Preparation of the global regulatory strategies and ensuring cross functional project team are aligned with the regulatory requirements to ensure timely submission.· Participating in authoring core CMC dossier for new product development.· Review and updating CMC dossier for new marketing authorization application for exiting products and ensuring latest regulatory guidance is considered for submission.· Participating in dossier assessment and evaluation of dossier for any potential compliance risk to avoid business risk and company reputation.· Management, advocation and supporting global CMC team responsible for product management by discussing regulatory strategies and ensuring optimized strategies prepared for prompt approval with minimal questions.· Participate in continuous improvement of company’s regulatory systems.· Prepared robust regulatory strategies for setting up alternative Drug Product and Drug Substance manufacturing site, by considering global marketing status.

Cambridge, Cambridgeshire, Gb

As ARPD, responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables including in the following key areas:• Clinical Trial applications (CTA): submission planning & delivery of global applications; co-ordination of Agency query responses to assigned timelines; CTA maintenance and close out of approved applications globally and according to local regulatory requirements• Leading complex cross-program global submissions for study protocols, Investigator Brochures, toxicity management guidelines, and Development Safety update reports; planning, tracking and coordinating submissions and leading cross-functional colleagues for the generation and delivery of Agency query responses• Supporting regional Regulatory colleagues for Agency interactions to gain feedback on new clinical study design; contributing to regional strategy considerations as applicable• Responsible for preparing, planning and executing submission of quality dossier of investigational medicinal product (qIMPD)• Tracking of dossier component timelines to an assigned delivery, contributing to team problem solving, communication & presentation of issues and updates to leadership. Support for global regulatory colleagues to meet regional delivery requirements.

Durham, North Carolina, Us

I am acting as a subject matter expert (SME) for providing high quality strategic regulatory consultation to clients focusing on the development pharmaceutics and impacting critical quality attributes of the product. I am accountable for the ensuring first time quality of all task delivery to clients. Daily activities include but not limited to planning regulatory strategy, interacting directly with regulatory agencies and attending cross functional team meetings for ongoing projects to support new product and lifecycle management applications.GRA expert responsible for authoring high quality technical documentation for initial marketing authorization application (MAA), post-authorization lifecycle management and renewal of medicinal products.Experience in authoring quality dossier sections for the biopharmaceutical & synthetic products for IND and CTA submissions.Responsible for management work-sharing procedure for critical changes to product quality and labelling and line-extension application to introduce new strength with change of formulation.Provide expert regulatory advice on CE marking of drug-device combination products which are integral and non-integral part (co-packaged) medicinal product.Participate in authoring scientific advice meeting and authoring briefing document for meeting with European competent authority for change in the critical quality attributes of well-established & new products.Perform systematic dossier gap analysis as per the applicable international and manufacturing standards to provide formal assessment and corrective planning for strategic business unit.Review change control and provide regulatory assessment for change proposals for efficient and timely implementation of the proposed changes.

• Providing technical support and lead product formulation development projects from laboratory trial to scale up to industrial production.• Personally responsible for advising manufacturers and business partners/key stake holders relating to regulatory requirements for projects.• Responsible for planning and attending team meetings within Medicom organisation and also, with external key stake holders/business partners.• Knowledge and experience in using the principles of cGMP/ICH for sterile manufacturing environment for ophthalmic products.• Providing subject matter expertise for formulation and method development for sterile unit/multi dose eye drop solutions, eye gels, eye ointment and eye emulsion.• Planning, preparing, compiling and submitting initial marketing authorisation and renewal application for national and global health authorities through MRP/DCP. • Preparation and update STED Technical File and supporting documents for CE Mark Medical Devices e.g. – risk analysis, ER Checklist, Clinical Evaluation, Biological Safety Evaluation and Product Labelling.• Efficiently communicating and obtaining licensing relevant information from manufacturing sites.• Writing technical reports and reviewing CTD Module 3 Documents, manufacturing protocols.• Preparing & updating SmPC’s, PIL’s and labelling in accordance with new QRD templates for Medicinal Products.

• Ensuring efficient, quality and timely delivery of operational support associated with major European and global initial marketing authorisation applications for Medicinal Products• Determining and applying post license variation application (Type IA, IB & II) for company products for life cycle maintenance national & MRP/DCP products in NeeS/eCTD format• Perform gap analysis review on CMC Module 3 sections for established and new products• Extensive experience in the submission of various SPC and labelling changes including PIQU/PAGB applications and notifications under article 61(3)• Oversight of regulatory issues in relation to medical devices in EU and Middle East countries, including technical file preparation mainly for class I & IIa Medical Devices• Identifying and correcting any non compliance associate with licenced medicinal/CE Mark products• Preparation and submission of change notifications to competent authorities• Approving artworks for medicinal products in compliance with terms of registration dossier and its implementation at manufacturing site• Organising and participating in key manufacturing and regulatory discussions meetings with manufacturing and Quality team• Presenting clear arguments to resolve the RFI/CAR related to the registration of medicinal/CE Mark products• Preparing and approving Technical and Quality Agreements for Critical Vendors• Helping hand to PV department for preparation of pre-Pharmacovigilance audit & PSUR update• Support the management review meeting as per the company Quality management system: ISO 13485:2003

• Undertaking the role as Regulatory Affairs personnel, ensuring the accurate registration and licensing of the company’s products and renewal approvals to strict deadlines• Preparing registration dossier (CTD Format) applications and representing the company to regulatory authorities, utilising scientific knowledge as well as legal and business acumen to ensure products comply with the required legislation• Developing and presenting clear arguments and explanations for new product licences and licence renewals and collating and evaluating information in a variety of formats• Personally responsible for advising scientists and manufacturers relating to regulatory requirements as well as playing a key role in hosting MHRA, USFDA and MoH regulatory audit• Demonstrating sound knowledge of the registration requirements of countries such as the Middle East, USA, EEA and non EU • Additionally accountable as Quality Assurance Controller, responsible for quality monitoring and assurance and ensuring all products remain free from errors and are of the highest quality• Actively involved in the review and updates of the quality management system and standard operating procedures in compliance with the latest legislations• Playing a lead role in the design and implementation of internal quality control audit programmes• Ensuring adherence with GMPs with responsibility for a variety of tasks including sampling, inspection and documentation review activities• Providing high levels of technical information relating to company products and handling customer queries promptly and efficiently• Providing assistance to senior management in conducting formal procedural enquiries and investigations to determine the cause of quality problems and recommending verbal and/or written corrective action• Demonstrating a complete knowledge of a variety of specialist computer applications required in registration dossier preparation and quality management

• Working on the medicine counter providing assistance to the Pharmacist, dispensing prescriptions and organising the dispensary area• Initially starting as shelf stacker gaining further responsibility after just a month, responsible for checking and organising floor stock as well as managing local deliveries to patients• Carrying out regular stock takes as well as sending orders and checking the daily deliveries• Dealing with customer queries in a professional, efficient manner and providing advice relating to general medicine and illness• Successfully completing the medical assistant course and attending seminars organised by GSK and Caudalie Cosmetics

Master Of Pharmacology, Life Sciences

Bachelor Of Pharmacy, Pharmaceutical