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Compliance Regulatory Affairs Manager

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  • Job
    Full-time
    Junior & Mid Level
  • Research & Development
  • London

Requirements

  • Life Science Degree or equivalent in education and experience
  • Dependent on individual aptitude, but would expect a minimum of 2-3 years’ experience of a broad range of regulatory work in the ethical pharmaceutical industry
  • Knowledge of operational aspects of regulatory affairs
  • Compliance and Quality mind-set
  • Ability to be innovative and a creative problem solver with quality and compliance approach
  • Excellent communication and interpersonal skills
  • English

Responsibilities

  • Co-ordinate UK RA publishing operations to ensure effective management of workload within the UK RA Compliance Team
  • Drive the development and implementation of end-to-end best practice relating to country publishing activities to ensure the efficient transmission of technically high-quality submissions are consistently made to UK HA
  • Support onboarding and act as mentor of UK Regulatory Publishing and Compliance Associates
  • UK Regulatory Information Management (RIM) Subject Matter Expert, ensuring UK data compliance in the global RIM system
  • Actively representing UK RA in the Global RA Process Improvement and Excellence Network
  • Support the preparation and involvement of UK RA in internal global audits and external inspections, including CAPA management
  • Support project management and implementation of pan-portfolio regulatory initiatives to ensure efficient and compliant outcome to ensure business continuity
  • Support Regulatory Compliance and Process Lead to address potential quality issues and emerging compliance concerns and recommend solutions, providing backup support, as needed with quality incidents/deviations in the appropriate system

FAQs

What is the primary purpose of the Compliance Regulatory Affairs Manager role?

The primary purpose of the Compliance Regulatory Affairs Manager role is to ensure efficient and effective national publishing operations for Marketing Authorisation submissions and to support proactive compliance with key Regulatory Affairs (RA) procedures.

What qualifications are required for this position?

A Life Science Degree or equivalent in education and experience is required for this position.

How much regulatory experience is expected for applicants?

A minimum of 2-3 years’ experience in a broad range of regulatory work in the ethical pharmaceutical industry is expected, depending on individual aptitude.

What skills are essential for this role?

Essential skills for this role include knowledge of operational aspects of regulatory affairs, a compliance and quality mindset, innovative and creative problem-solving ability, and excellent communication and interpersonal skills.

What are the key responsibilities of the Compliance Regulatory Affairs Manager?

Key responsibilities include coordinating UK RA publishing operations, driving the implementation of best practices for publishing activities, mentoring associates, managing UK data compliance, supporting audits and inspections, and addressing potential quality issues.

Where is the position located?

The position is located in London, United Kingdom, specifically at The Westworks.

Are there opportunities for professional development in this role?

Yes, the role involves mentoring and supporting the onboarding of associates, providing opportunities for professional development within the UK Regulatory Publishing and Compliance Team.

What is the employment type for this position?

The employment type for this position is regular, and it is a full-time role.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. Around 108,000 people of more than 140 nationalities work at Novartis around the world.

Culture & Values

  • Inspired

    Engage our people. Strive for patients. Live our purpose

  • Curious

    Learn. Be open. Be self-aware

  • Unbossed

    Create clarity. Serve others. Own your actions

  • Integrity

    Be honest. Have courage. Do what’s right

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