Manager Project

Ushma Patel

** ***** *****, ***********, ** *****

609-***-**** ~ *****.*****@*******.***

PROFILE

An enthusiastic Regulatory Affairs professional with over 15 years of strong Regulatory, Quality Assurance and Product Formulation and Development experience. Works well independently and as part of a matrix team with the aptitude to assess and make calculated decisions. Conscientious and thorough yet possesses the ability to work quickly under pressure. With proficient organisational, problem solving and strong interpersonal skills has a positive, enthusiastic and self-motivated attitude towards meeting objectives and goals.

SKILLS

Excellent time management skills with the ability to prioritize tasks to meet challenging deadlines

Enthusiastic team member and self-starter who can engage colleagues to meet goals

Strong analytical, diagnostic and problem solving skills with the ability to provide innovative solutions

Communicator, verbally and electronically with a high level of attention to detail to a diverse audience

Able to work under pressure and meet deadlines and targets within a GMP/QA environment

Ability to adapt and change to different environments and work effectively across global matrix teams

CAREER HISTORY

GLAXOSMITHKLINE, Warren, NJ, USA Sept 2017 – Sept 2018

Regulatory Affairs Manager, Consumer Healthcare

US Regulatory Affairs Manager responsible for a portfolio of 10 products in the Digestive Health/Nutritional category.

Label content creation and approval for OTC, dietary supplement and nutritional products

Review product labelling/advertising to ensure compliance with federal regulations

Develop, review and approve artwork and promotional copy to ensure regulatory compliance

Review CCDS and ensure alignment to local label for all the products managed

Labelling compliance project - identify deviations between companies’ core data standard and local registration

Monitor the regulatory environment and provides assessments of the impact of new and changing regulations

Support functional activities to ensure both short and long term department and company objectives are met

Manage and update local databases and systems to ensure compliance

Planned and managed the coordination and compilation of regulatory submissions and other correspondence in accordance with regulatory agency regulations and guidelines

Systems used – Documentum, OTCDocs, Polaris, Phoenix, Rosetta Phoenix, SharePoint online

ASTRAZENECA, Home-based, NJ, USA Jul 2015–Sept 2017

Regulatory Affairs Project Manager

Project Manager for several phase 1 and 2 clinical studies in the Oncology space, ensuring quality regulatory submissions are dispatched to global agencies within company timelines.

Contribute to solutions to regulatory issues

Provide operational regulatory input and guidance in cross-functional teams.

Prepare content plans and coordinate submission with Regulatory Operations and/or CRO

Work flexibly within and across therapeutic areas to provide broad regulatory support to ensure the delivery of product team and business objectives.

Prepare and deliver regulatory operational plans for allocated studies.

Work effectively with global regulatory affairs personnel and with global/regional cross-functional teams to plan, prepare and deliver both simple and increasingly complex submissions across a range of markets (US, EU, Canada, Australia, S. Korea)

Coordinate, prepare and review of DSUR

Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the product development program.

Systems used – eCTDXpress, ANGEL, CORTELLIS,

GENPACT PHARMALINK (Formally Pharmalink Consulting), Short Hills, NJ, USA Nov 2009 – Jul 2015

Regulatory Affair Manager (Celgene) (Jun 2014 – Dec 2014)

Support Global Regulatory Strategy Leads and Functional team to implement plans for oncology/haematology/Solid tumour for identified products in development.

Preparing and validating content plans and coordinating submission with Regulatory Operations

Study start up activities such as IP release, working with US RL on Transfer of Obligations, reviewing 1572 forms

Approving site activation check lists for clinical product release

Coordinate preparation and review of DSUR, PSUR, NDA AR, NtFs,

Labelling review

Medwatch safety reports reviews

Systems used - eCTD viewer, eQRMS, eSub, Powerpoint

Project Manager (Pfizer) (Apr 2011 – Jun 2014)

Managed, supervised and trained a team of 7+ consultants in USA and UK. Various projects were executed around client change management systems and regulatory product registration system. Lead project team to identify and implement improvements. Prepared deliverables and presentation material to clients to ensure project delivery against tight deadlines. Recruited, managed and developed regulatory professionals. Perform metrics and report to upper management using various tools.

Senior Regulatory Affairs (Pfizer) (Nov 2009 – Apr 2011)

Worked on various projects for multiple teams. Projects ranged from CTD building, CMC authoring, QC review, conversion of part two format to CTD, reviewing and compiling complex documents.

Systems used - PDM, GDMS, PfLICC, RADARS, TrackWise, GRS, SPA, RightTracks 2, Rosetta Pyramid, Microsoft application, Sharepoint

GLAXOSMITHKLINE, Ware, UK Jan 2003 – Sept 2009

Regulatory Conformance Executive (Sept 2006 – Sept 2009)

Ensured compliance of global drug product and quality statutory regulations are maintained on site for the manufacture of pharmaceutical products supplied locally and internationally.

Team lead for several pharmaceutical global products, for various therapeutic areas at different product stages

Responsible for site Regulatory and Corporate compliance

Author and approved Product Quality Specifications, Raw Material specifications and Laboratory Analytical Methods to ensure site compliance with Registered, Pharmacopoeial and Corporate standards

Involved with Quality by Design submission to ensure quality is built into finished products

Review and approved Chemistry Manufacturing Control (CMC) sections for product dossiers (MAA, NDA, JNDA)

Provided advice during any changes to processes or specifications etc for internal change control purposes

Involved with discussion on strategy planning for local changes

Responsible for ensuring Site Master Files are updated and concurrent with activities for audit purposes

Involved with Variations, Response to Questions, Prior Approval Supplement

Liaise closely with both pre-approval and post-approval regulatory groups within GSK, globally

Analyse regulatory guidelines, polices and actions to determine regulatory and legal impact on company

Carry out Pharmacopoeial reviews, and drafting of Pharmacopoeial monographs

Developed local Standard Operating Procedures

Scribe and front in both internal and external (FDA, MHRA, ANVISA, KFDA) regulatory audits

Perform trending for deviations within group to identify non-conformance causes and propose corrective and preventative actions

Active transfers and source transfers across different global markets and cross-matrix teams

Associate Scientist, Physical Properties & Development Group (Jun 2004 – Sept 2006)

Responsible for testing Product Line Extensions, NCE’s and stability samples.

Involved with project management of several projects, method development and method validation

Performed computer validation of new equipment sourced and purchased into the group

Responsible for monthly housekeeping and health and safety within the team and collating metrics

Trained new starters and involved with school liaisons to create awareness of the industry

Working to GLP, GMP and cGMP standards

Technologist, New Product Introduction (Jan 2003 – Jun 2004)

Primary role was to support the Product stream on a day-to-day basis, via product transfer activity and new product introduction.

Daily stream activities included project management and continuous improvements

Involved in training, development and troubleshooting

As a secondary role involved with Fine Chemical's, Stability Testing and Method transfer

Assisted with both routine and non-routine work and working in teams to meet tight deadlines

RUSCO PHARMACEUTICALS, Margate, UK Jun 2001 – Sept 2002

Product Development Analyst

Summer vacation job where I was in charge of the research and development of medicinal products.

Responsible for ordering of raw materials and actives to meet production requirements

Filling out marketing licences for manufacture of products

Formulation of cough medicines

Assisted Quality Control department. Analysed and tested raw materials and finished products according to specific methods and followed Standard Operating Procedures whilst working to Good Manufacturing Practice

FLEET LABORATORIES, Watford, UK Jun 2000 – Jun 2001

New Product Development Chemist

During an industrial placement from University was responsible for product stability testing

Formulated and developed new and existing toiletries and skin care products

Ordered raw materials, formulated and despatched samples out to customers

Worked to customer briefs and met tight deadlines.

EDUCATION & QUALIFICATIONS

Real Estate Licence – Realtor Associate 2009

Lean Sigma 2005

BSc (Hons) Pharmaceutical and Cosmetic Science, DeMontfort University, Leicester, UK 1998 – 2002

OTHER INFORMATION

Nationality: Dual: British/ US

Languages: English, Gujarati, French (basic)

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