THE COMPANY

Fusion Pharma provides a bespoke consultancy service within the pharmaceutical industry for Regulatory Affairs activities. Our first priority is to have a positive workplace culture where employees feel respected and valued. To achieve this, we only hire talented, dedicated and passionate individuals who share these same values. We take our work-life balance seriously and offer remote and flexible working options along with 6 weeks holiday each year and an attractive Vitality private healthcare plan. By prioritising this, our clients benefit from our energetic and committed team who work hard to make our clients’ goals, their goals!

We continue to grow and are delighted to be recruiting for our next member of the team in the Regulatory Affairs Department, reporting into Head of Regulatory Affairs.

 

THE ROLE

There are two aspects to this role as it is split between working on client projects and company projects:

 

1) Client projects

There are opportunities to utilise and grow your experience by supporting client projects. You will be exposed to working with our established ‘big pharma’ clients as well as supporting start-ups, such as:

  • Being responsible for a portfolio of products within our outsourcing model
  • Work collaboratively with internal and external stakeholders to ensure the Regulatory aspects of projects are managed in line with clients’ expectations
  • Representing the Regulatory department during internal/external audits or Health Authority inspections.

 

2) Fusion projects

We strive for continuous improvement and with this brings several activities that the whole team contributes towards, such as:

  • Project management
  • Writing/reviewing SOPs, blogs and marketing materials
  • Regulatory Intelligence activities
  • Business development activities.

 

THE ESSENTIAL EXPERIENCE

  • Life Cycle Management activities within a UK and/or EU Affiliate
  • Compilation and submission of CMC and safety variations, Art 61(3) applications, PBRERs/PSURs, MAAs
  • Experience with National, DCP/MRP and CP licences
  • Updates to SmPCs, prescribing information, PILs and labelling, including mock ups
  • Update to Regulatory tracking systems such as Documentum
  • Communication with the Health Authorities
  • Proven regulatory strategy skills

 

THE ESSENTIAL REQUIREMENTS

  • Life Sciences degree
  • Fluent in written and spoken English with excellent communication skills and attention to detail
  • Minimum of 3 years Regulatory Affairs experience (aligned with client work as described above)
  • Proficient in Microsoft Office applications with the ability to learn new electronic systems
  • Proven competency in working autonomously and multi-tasking in fast-paced environment
  • Committed to representing Fusion Pharma to a high standard, face to face and remotely
  • Role requires an enthusiastic, motivated and driven individual
  • The successful candidate will have a professional work setting for company video calls and a high-speed, reliable internet connection.

 

THE BENEFITS

  • Competitive salary
  • Permanent and full time Flexible working hours
  • Remote working
  • 6 weeks holiday
  • Private healthcare
  • Pension

 

Please send your CV to hello@fusion-pharma-limited.com if you are interested in this position.