Business Consultant (IT and Regulatory affairs)
- Recruiter
- Vichag LTD
- Location
- Birmingham, West Midlands
- Salary
- Gross per annum: £42,000 to £46,000
- Posted
- 07 Sep 2018
- Closes
- 05 Oct 2018
- Ref
- Vichag/BC/070918
- Sectors
- IT, Business Analysis, IT Support, Project Management
- Contract Type
- Permanent
- Hours
- Full Time
Introduction
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.
Key Responsibilities
· 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
Essential Experience
· 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