Senior Regulatory Affairs Officer

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Reference2778232611
Job TitleSenior Regulatory Affairs Officer
Job TypePermanent
Job Scope
Business AreaRegulatory Affairs
LocationWelwyn Garden City, UK
SalaryCompetitive + Benefits
Websitehttp://careers.roche.com/unitedkingdom/
Apply Online
Description

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):

    http://careers.roche.com/unitedkingdom/jobs/united-kingdom/regulatory-af...

    Agency
    OrganisationRoche
    Phone
    Fax
    Emailuk.recruitment@roche.com
    AddressRoche Products Limited
    6 Falcon Way, Shire Park
    Welwyn Garden City
    AL7 1TW
    United Kingdom