Methodical Regulatory Officer experienced in managing large client caseloads through diligent planning and project coordination. Investigates with due care and diligence to identify concerns and achieve positive outcomes. Communicates and presents confidently to engage staff, stakeholders and clients in programme activity.
Overview
3
3
years of professional experience
1
1
Certification
Work history
Regulatory affairs professional
Britannia Pharmaceuticals Ltd
09.2021 - Current
Compile and submit variations (DCP/MRP/National) in line with the variation regulations, SOPs and national Competent Authority requirements
Compile and submit renewals prior to MA expiry in line with the variation regulation, and national Competent Authority requirements
Lead Regulatory approval processes for licence maintenance and MA submissions in new markets
Liaise with Regulatory Authorities to agree submission strategies and resolve issues
Ensure submissions are made in agreed timeframe and in line with current health authority regulations to support department schedules/priorities for launch and maintenance
Update relevant functional stakeholders of any delays and/or schedule conflicts in fulfilling regulatory plans
Build relationships with key stakeholders and represent the business in a responsible manner according to company values, in order to communicate policies and strategies and negotiate outcomes
Analyse Regulatory issues, propose and agree solutions with the manager and communicate effectively with key stakeholders, including local, regional and partner colleagues
Analyse Regulatory risks, propose and agree mitigation plans with the manager and communicate effectively to the business
Manage compliance within defined portfolio/activity streams in line with business expectations
Develop effective ways of working with other functions) to deliver agreed objectives
Raise Change Controls for regulatory activities within the department
Create and maintain SOPs and Work Instructions for the Regulatory function
Support internal/external inspections and audits
Ensure that specifications and labelling are appropriately controlled
Ensure Regulatory documentation is appropriately archived.
Boots Pharmacy
10.2020
Listen and provide advice to customers on how to manage prescriptions
Merchandising and refilling stock
Accuracy checking prescriptions
Retrieving EPS scripts
Supplying patients with information and education on their prescription.
Estee Lauder Companies
12.2019
Help customers find the perfect skin care product which matches their needs
Traveling to various brands around London and adjusting my skills to the brand