Line management of 1 or more regulatory professionals
To submit regulatory applications for the UK licence portfolio, expediting approvals as required meeting market demand.
To work with internal and external customers to ensure work is prioritised in accordance with business needs
To ensure high quality data and standards are used in support of all regulatory applications.
To provide regulatory support to project teams, stakeholders and customers, as required.
Major Job Challenge(s):
Management of a large and diverse licence estate
Meeting team objectives whilst addressing frequent and often unscheduled issues and changing priorities.
Maintaining familiarity with the complicated system of regulation and control of medicinal products and adapting to the rapid changes in this area.
Organisation of own and team workload to meet departmental and Company targets
Acceptance of data and documentation for use in registration submissions
Management of own and direct reports’ projects
Regulatory strategy for post-approval changes
Setting of direct reports’ objectives
All personnel within UK Regulatory Affairs
EU Regulatory Affairs
Manufacturing, Packaging, QC testing and QA release sites
Portfolio and Project Management
Product marketing and management
Medical Affairs, Medical Information and Pharmacovigilance
Customer Sales Marketing
Degree in life sciences/pharmacy or equivalent qualification(s)
Significant experience in the Pharmaceutical Industry, including experience within EU or UK Regulatory Affairs. Additional experience in R&D, Quality or Operations desirable.
Good standard of technical knowledge - CMC experience desirable
Coaching and supervisory experience
Knowledge of UK and/or EU experience and knowledge of regulatory procedures
Understanding of processes and departments within a pharmaceutical company
Excellent oral and written communication
Ability to work under pressure and to tight time deadlines
Effective time and organisation management
Analytical (data rational)
To manage post approval activities on a defined group of nationally approved products
Review, compile and submit high quality regulatory submission packages to the UK MHRA and other EU Regulatory agencies where applicable.
To supervise, mentor and provide training for UK Regulatory team members
To work closely with manufacturing, QA, packaging testing, artwork origination and release sites, plus Medical and Pharmacovigilance departments, in order to support the preparation, compilation, review and submission of high quality regulatory documentation in accordance with UK requirements, legislation, guidance and Teva procedures
To work closely with EU RA Competence Centres in order to provide timely UK specific documentation and/or information in support of EU new submissions and/or variations and renewals.
To co-ordinate resource effectively to ensure that Regulatory approvals are secured in line with business timelines, and regulatory project support is provided
To identify, initiate and prioritise areas for process improvement, and manage change as required
To ensure that all activities fully comply with Departmental and Company SOPs & Work Instructions.
To ensure that all internal tracking tools and electronic databases are maintained, accurate and complete.
To represent UK Regulatory Affairs in cross functional teams
To understand and communicate complex issues to other Regulatory, Quality, Supply Chain, Product Management Medical, Pharmacovigilance, EPD and Senior Management colleagues
To have excellent verbal and written communication skills
Create opportunities for learning and development
Other duties as required at the direction of Principal Regulatory Affairs Officer and/or UK RA Manager