Regulatory Operations Management Professional

Meticulous and detail-oriented professional with versatile experience in regulatory submissions/operations, quality control, and stakeholder collaboration within pharmaceutical industry. Adept at streamlining processes, ensuring compliance, and navigating Veeva Vault PromoMats software to facilitate timely approvals. Skilled in leveraging industry-standard publishing systems, such as ISI Publisher, ISIToolbox, eCTDXPress, and Microsoft Word to assemble accurate and consistent submissions. Proven expertise in Medical-Legal Regulatory (MLR) review processes, project management, and process improvements aimed at enhancing overall business success. Strong background in pharmacy operations, including drug procurement, sales optimisation, and training support staff. Highly effective communicator with track record of fostering strong relationships with internal and external stakeholders.

Areas of Expertise

Regulatory Submissions

Process Improvement

Strategic Planning & Analysis

SPOR

Quality Assurance & Control

Pharmacy Operations

ECTDXPress & Veeva Vault

ISO IDMP

Microsoft Office Suite

EMEA & FDA Compliance

Documentation & Reporting

GMP inspections

Certifications

Janssen EMEA iMedical Review – Business Process Training for Agencies, 21 Sep, 2022

EMEA iMR Digital Asset Management – Agency and Internal Submitter, 21 Sep, 2022

iMR changes related to SOP 201 Exception, 21 Sep, 2022

SOP Exception Training for Pharma EMEA HCBI – 201 Janssen Generated Materials for use with HCP's, Patient Organisations, Patients and the Public in the EMEA, 21 Sep, 2022

EMEA iMR - Complete Guide to iMR, 21 Sep, 2022

MSL Content Publishing to iConnect (inc.eCalls), 21 Sep, 2022

Career Experience

Fishawack Communications Ltd, London, UK 2021 to 2023

Senior Regulatory Submission Specialist

Executed meticulous file specification verification to ensure compliance with client and agency standards. Streamlined submission process by proficiently linking, tagging, annotating, and managing error-free submissions to facilitate prompt approval decisions.

Delivered timely status updates to team, promptly shared downloads, and distributed reviewed submissions for effective collaboration. Updated and maintained accurate and detailed compliance records.

Oversaw Medical-Legal Regulatory (MLR) review processes for clients, enabling successful planning and approval of over 100+ pharmaceutical messaging, involving document submission, retrieval, and distribution for review/revision.

Developed strong expertise in utilisation of Veeva Vault PromoMats submission software by effectively navigating associated processes for assigned accounts.

Maintained effective coordination with internal and external stakeholders to ensure completion of required activity prior to next milestone.

Holiday Inn Express – Stay Belvedere Hotels Ltd - Vauxhall, Lambeth Road, UK 2021

House Officer

Performed regular welfare checks on service users for communicating well-being to relevant stakeholders. Developed fire safety procedures and evacuation plans to ensure preparedness in case of incidents. Welcomed new arrivals and provided thorough orientations to communicate hotel policies and inductions.

Provided support in managing GP registrations and scheduling appointments of service users.

Supported resolution of service user issues by coordinating with Migrant Help and provided assistance throughout process.

DXC.Technology (CSC) Hyderabad 2017 to 2021

Regulatory Publishing Associate Professional

Executed QC tasks within electronic publishing system for accurate published output. Conducted QC reviews of documents prepared by team. Provided valuable support to senior submissions teams in maintenance of electronic Common Technical Document (eCTD) lifecycle. Provided support for lifecycle publishing project for assisting with tasks, such as formatting Word documents, creating bookmarks, hyperlinking, and conducting quality control (QC) checks. Assisted with internal process development, such as Bristol Myers Squibb Publishing Process in ISI Publisher and PRISM Automation Process.

Achieved excellence in leading high-performing Document Level Publishing for Bristol Myers Squibb and successfully published third-party documents from PRA Health Sciences, Charles River Laboratories, and others.

Utilised standard publishing systems and utilities, such as ISI Publisher v4.0.0200, ISIToolbox v6.3.0200, Adobe Acrobat, and Microsoft Word to effectively create and compile client deliverable documents/submissions.

Ensured accurate/consistent quality improvements in regulatory submissions contributing to enhanced business success.

Gained extensive experience/expertise in PRISM/CARA, ISIToolBox, ISI Publisher, eCTDXPress, Skillport, and SharePoint.

CARE Hospitals, Hyderabad 2015 to 2016

Pharmacist

Implemented effective measures to ensure pharmacy maintains ample supply of life-saving drugs and offers reasonable prices to meet needs of patients. Interpreted written prescriptions, checked for drug interactions/allergies, and entered prescription/patient data into computer systems. Interpreted and processed medication orders under supervision of pharmacy director to ensure accurate and timely fulfilment.

Provided effective training and guidance on pharmacy support technicians.

Reviewed physician orders to assess and ensure accuracy/safety prior to further processing.

Conducted thorough reviews and implemented enhancements to procurement, sales, and billing systems, resulting in notable 10% increase in sales.

Additional Experience

Customer Support Associate Amazon India Private Limited, Hyderabad, India

Addressed and resolved over 80+ customer queries by utilizing strong interpersonal skills and conflict resolution techniques.

Maintained effective communication with customers, senior management, and sales team to better understand customer needs and recommend appropriate solutions.

Awards & Achievements

DXC Quarterly Champ Awards, Issued by Lokendra Sethi Vice President HR India – Aug 2020

Education

Master of Science: Master of Pharmacy - Pharmaceutics Jawaharlal Nehru Technological University, Hyderabad

Languages

English – C2 Arabic – B2

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