Business Consultant (IT and Regulatory affairs)
Vichag is one of UK’s rapidly growing Business consulting companies specialising in providing consulting and business solutions to Industry and public sector enterprises across UK & Europe. Currently we are looking for a Business consultant specialising in IT and regulatory affairs in the pharma domain of our UK operations.
· To develop solutions for ease in use of IP (Insight publishing), NeeS, eCTD format in Pharma domain.
· To update the databases of dossier packages prior to submission to the authorities
· To meet the stringent timelines of projects and solutions development
· To conduct gap-analysis for existing product information and submit the variations to bring the products in compliance.
· To actively participate in the departmental and cross functional team project meetings.
· To prepare and submit compliance documents for approvals and to implement the business strategy.
· To serve as the single point of contact for the business operations and various functions such as validation and regulatory requirements.
· To manage new MAA (Marketing Authorisation Applications) and product lifecycle maintenance activities including variations, renewals and safety updates.
· To Author CTD (common technical document) dossier sections as per regulatory guidelines
· To develop training procedural documents and delivery thereof.
· To advice on various initiatives for post approval activities such as maintaining CFCC (cross functional change control).
· To evaluate new data sources, suggest proven methodology and develop processes for data analysis
· Proven experience in IT solutioning, regulatory controls and in demonstrating analytical skills in Pharma domain
· Proven experience in leading client facing teams
· Proven business process understanding of Pharma domain
· Knowledge of regulatory guidelines and IT landscape issues
Skill Sets Required
· Thorough understanding of technologies and applications such as IP, Nees, eCTD as used in pharma domain
· Exposure to latest digital solutions and development of IT roadmap
· Understanding of TDS (Technical documentation System)
· Good oral and written presentation skills
Education Level / Qualifications
· Masters in Science
Travel - Occasionally within UK and abroad
Last date to apply: 05/10/2018