New look for TOPRA

Over the past year or so, the TOPRA Board has been reviewing the organisation’s strategic goals and our communications plan for the next 10 years and in an increasingly online environment.

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Human medicines highlights - Issue 57 - November 2013

The November 2013 issue of the European Medicines Agency's newsletter 'Human medicines highlights' is now available.

All issues of the newsletter are available on the Agency's website.

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Regulatory Affairs Associate II

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Job TitleRegulatory Affairs Associate II
Job TypePermanent
Job Scope
Business AreaGlobal Regulatory Affairs
LocationUK South East
Apply Online

The Regulatory Affairs Associate II provides regulatory support and expertise on assigned programmes, and is responsible for specific pieces of moderately complex projects. In addition, the Regulatory Affairs Associate II reviews scientific documents intended for submission to regulatory authorities. This is a fantastic opportunity to work with cutting edge science and an organisation that is committed to your career development.

Key responsibilities

  • Assists with the planning and preparation of submissions to regulatory authorities, with minimal supervision
  • Independently solves problems of moderate complexity and scope, with limited supervision
  • Determines the best and most appropriate methods and procedures on new assignments independently
  • Applies knowledge of regulatory requirements to the review of scientific documentation intended for submission to regulatory authorities
  • Analyses new regulations and guidelines and makes process improvement recommendations to group
  • Prepares and delivers effective presentations for department meetings
  • May represent Regulatory Affairs department on assigned project sub-teams and/or task forces, with supervision
  • May conduct training, with supervision
  • Performs other duties as assigned

Minimum Qualifications

  • Experience in preparation and/or submission of documentation for European agencies: such as CTAs, PIPs, variations PSURs.
  • Demonstrates effective, self-sufficient communication skills, especially in peer-directed presentations
  • Displays sound project management skills
  • Exercises good judgment within defined procedures and practices to determine viable solutions
  • Displays good interpersonal skills and ability to deal effectively with a variety of personnel
  • Demonstrates advanced knowledge and understanding of applicable regulations
  • Fluent written and spoken English and second European language an asset

To apply please click on the link below:


Senior Regulatory Affairs Officer

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Job TitleSenior Regulatory Affairs Officer
Job TypePermanent
Job Scope
Business AreaRegulatory Affairs
LocationWelwyn Garden City, UK
SalaryCompetitive + Benefits
Apply Online

At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.

To further strengthen our national Regulatory Affairs group, part of the Medical Department, we have an exciting opportunity for an experienced regulatory professional. As a Senior Regulatory Officer (known within Roche as a Lead Regulatory Scientist) you will provide regulatory strategic and technical advice within the department and across the business, and be responsible for the national regulatory management of marketed medicines and development products in a specific therapeutic area.

In this role you will:

  • Represent UK Regulatory Affairs at EU level and in in cross-functional teams and task forces to support the business
  • Build contacts and understanding across the business, identify business opportunities for Regulatory Affairs
  • Proactively seek knowledge in specialist areas, interpret and communicate impact analysis within Regulatory Affairs and across relevant business areas
  • Demonstrate leadership, proactivity and department level approach to work, thinking beyond immediate responsibilities and applying knowledge to new situations
  • Ensures quality regulatory submissions are made in a timely manner in collaboration with colleagues to maintain licences compliantly. Ensure approved changes are implemented
  • Demonstrate current regulatory knowledge. Can find, understand and apply regulations and guidance relevant to our work
  • Provide specific guidance on regulatory issues to support internal customers
  • Know the brand strategies. Timely communication of regulatory activities and timelines to support brand planning
  • Assess technical/scientific content of proposed national submissions to meet requirements. Propose solutions to correct deficiencies
  • Represents Regulatory Affairs as primary product contact cross functionally, interfacing with local brand teams and Headquarters Regulatory
  • Ensures questions and commitments from our national regulatory authorities (UK, Ireland, Malta) are proactively managed
  • be able to coach colleagues in their work
  • Contribute to efficiency and process improvement including development of best practices, SOP maintenance and appropriate tracking tools, templates
  • To ensure that personally and within the team: High ethical standards are maintained at all times, there is full compliance with all applicable laws, regulations, industry codes and internal policies and procedures
  • Qualifications:

    This role requires demonstrated good regulatory judgment, understanding the scientific content of regulatory documents and sound understanding of the regulatory environment. Key skills and experience are as follows:

  • University degree or equivalent, preferably in a scientific discipline. Further education or training in Regulatory Affairs desirable
  • Successful track record in Regulatory Affairs, including experience of EU or national management of CP, MRP and nationally licenced products through MAA, technical and clinical variations, and experience with UK CTAs. Experience in other aligned areas e.g. drug safety, clinical trials, development research and an understanding of drug discovery, development, manufacturing and marketing desirable
  • Able to plan and project manage large, complex activities
  • Good communication skills, teamwork, IT skills (MS Office)
  • To apply please click on the link below (or go to the Roche Career site):

    AddressRoche Products Limited
    6 Falcon Way, Shire Park
    Welwyn Garden City
    AL7 1TW
    United Kingdom

    TOPRA Annual Report 2012/13

    TOPRA's Annual Report for 2012/13 has now been published.

    Open digital edition

    Download as pdf

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