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Senior Manager of Regulatory Affairs

2 months ago

Worthing, West Sussex, United Kingdom Rayner Intraocular Lenses Full time

We are seeking a highly experienced and ambitious leader to join our Pharmaceutical Quality and Regulatory Affairs team at Rayner Intraocular Lenses. As the Head of Pharmaceutical Quality and Regulatory Affairs, you will play a critical role in ensuring the success of our commercial plans and the achievement of our strategic goals.

Key Responsibilities:

  • Develop and implement strategies with top management to drive business growth and improvement
  • Set and report on team objectives, ensuring alignment with company goals
  • Collaborate with global leadership to ensure the success of commercial plans and the expansion of our ophthalmic medicines portfolio
  • Ensure compliance with all applicable regulations in target markets, including the UK and US
  • Manage the Pharmaceutical QARA team, providing guidance and support to ensure the delivery of high-quality results
  • Maintain and deliver continual improvement of the Rayner Pharma QMS, ensuring it remains effective and efficient
  • Run a program of internal and supplier audits to ensure compliance with regulations
  • Host external regulatory body audits of the Pharmaceutical QARA systems
  • Monitor and report on key performance indicators (KPIs) relevant to the department
  • Manage relationships with key external stakeholders, including contract manufacturers, logistics contractors, and test houses

Requirements:

  • Registered with the MHRA as a Responsible Person for WDA(H)
  • Life Science degree or equivalent professional qualification
  • Thorough understanding of the manufacture, testing, and quality assurance of sterile products
  • Direct experience in a similar role, covering the creation, maintenance, and submission of pharmaceutical registration documents for the UK, EU, or USA
  • Experience in some area of ophthalmology
  • Experience as a Quality System leader in the pharmaceutical industry
  • Demonstrable knowledge of the regulatory environment relating to the manufacture of sterile products
  • Experience of sterile pharmaceutical products

We offer a range of benefits, including:

  • Private healthcare
  • Wellbeing allowance up to £300.00 a year
  • Monthly yoga sessions and quarterly massages
  • Annual program of fun events
  • On-site restaurant
  • Enhanced maternity and paternity leave
  • On-site parking