Manager Regulatory Affairs UK

  • Department: Regulatory Affairs
  • Location: Harlow, Essex
  • Education Level:
  • Employment Type Level: Full Time
  • End Date: 31-Jul-2018

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Overview

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.

  • Understanding complex data from a range of scientific and technical disciplines and re-presenting this data in logical and consistent manner.

  • Input into complex decisions

  • Effective line management


Decision Making:


Prime

  • 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

Shared

  • Setting of direct reports’ objectives


Referred

  • Recognition of the need to refer issues and decisions that are outside of the individual’s experience and competence


Relationships:


Internal:

  • All personnel within UK Regulatory Affairs

  • EU Regulatory Affairs

  • Manufacturing, Packaging, QC testing and QA release sites

  • Portfolio and Project Management

  • Business Development

  • Product marketing and management

  • Supply Chain

  • Artwork Origination

  • Legal

  • Medical Affairs, Medical Information and Pharmacovigilance

  • Customer Sales Marketing


External:

  • MHRA

  • Customers

  • Suppliers



Skills & Experience

Qualifications:

  • Degree in life sciences/pharmacy or equivalent qualification(s)


Experience:

  • 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:

  • Knowledge of UK and/or EU experience and knowledge of regulatory procedures

  • Understanding of processes and departments within a pharmaceutical company


Skills:

  • Excellent oral and written communication

  • Ability to work under pressure and to tight time deadlines

  • Effective time and organisation management

  • Negotiation

  • Initiative

  • Analytical (data rational)

  • Computer literacy

Specific Competencies:

  • Flexibility

  • Team Work

  • Action Orientation

  • Problem solving and Analysis

  • Business Acumen

  • Specialist Knowledge


Main Responsibilities


  • 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