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.

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.
• 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.
• 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.

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.

• 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.

• 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

• 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.
• 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

• 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