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Senior Manager, Regulatory

4 months ago

Sheffield, United Kingdom B Braun Medical Ltd Full time

Contract: Permanent

Working hours:, 37.5 hours per week, Monday to Friday

Hybrid: Office and home working. A minimum of 3 days a week working in our Head Office, Sheffield, S35 2PW. Employees are able to utilise our office facilities more should they wish to. This can vary depending upon work requirements. We offer free onsite parking.

Reporting to the Head of Regulatory Affairs you will collaborate and develop the Regulatory and Quality strategy for the UK. This role is responsible for the execution in delivery of the regulatory milestones including assessment of the probability of regulatory success together with risk analysis and mitigation measures required for the operation of the BBMUK.

You will provide leadership to the Regulatory & Medical Affairs teams, having responsibility for the pharmacovigilance, medicovigilance, medical information and product licensing activities. In this role you will be representing Regulatory Affairs on Local and Global projects ensuring the UK is seen as a driving force in supporting ‘The Next Decade strategy’

This opportunity really offers fantastic role exposure within a diverse organisation with an amazing purpose – we protect and improve the health of people around the world

Your main responsibilities will be:

  • Maintain extensive clinical/scientific expertise as a subject matter expert of the relevant therapeutic areas, products, company pipeline, medical technology and competitors.
  • Build capabilities, plans and systematic tracking of impactful Medical Affairs activities, including gathering actionable insights and disseminate throughout the organisation.
  • To act as Responsible Person, Local Safety Officer for Medical Devices
  • To lead and support with MHRA or other regulatory agencies in audits or issues relating to product complaints, vigilance or services working closely with Global Safety Group in all Divisions taking responsibility for resolving local issues
  • Responsible for developing UK Regulatory & Medical Affairs new product (pharmaceutical, medical device) / service launch strategy to ensure regulatory compliance through collaborative working with Sales & Marketing and Market Access Leadership.
  • Responsible for analysing and investigating complex and inter-linked digital and clinical issues in relation to digital clinical safety
  • To update BBMUK on changes in the regulations/guidelines governing promotion of medicines and medical devices in the UK ensuring that B. Braun procedures are updated to reflect these changes and deliver training to appropriate staff.
  • To develop and maintain strong internal and external relationships with regulatory, NHS partners and key opinion leaders to support in the delivery of BBMUK regulatory and business development strategies.
  • Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.

What you’ll need to succeed:

  • Pharmacy Degree (GPhC registered)
  • ABPI Medical Signatory
  • Experience in leading a team in a Medical/Clinical Research Department in a Pharmaceutical or Medical Device company or NHS (pharmacy/clinical/intensive care).
  • Knowledge of NHS and Health Economics.
  • Knowledge of current regulations governing sale and supply of medicines, medical devices (including ABPI code) and biocides and cosmetics.
  • Knowledge of pharmaceutical business and the associated regulatory framework.
  • Experience in the development and licensing of medical devices.

In return we will provide the following benefits:

  • 27 days annual leave plus bank holidays 
  • Potential annual bonus scheme
  • Free onsite parking, tea and coffee
  • Onsite subsidised canteen
  • Company Pension scheme - employer contribution match up to 7%
  • Life assurance 3 x annual salary
  • Group Income Protection Scheme
  • Private Medical Insurance option
  • Occupational Sick Pay
  • Assistance with further study
  • Learning and development opportunities
  • Enhanced family friendly payments
  • Aviva Employee Assistance Programme which includes access to digital wellbeing programmes
  • Aviva DigiCare Workplace App which includes access to a free digital GP and a health check
  • Recognition and long service awards
  • Professional subscription reimbursement when required for your role
  • Health and wellbeing activities
  • Financial education support
  • Access to our benefits app with fantastic discounts from hundreds of retailers and instant access to your digital payslip

Optional benefits:

  • Westfield Health Cash Plan
  • Blue Light Card 
  • Discounted gym membership
  • Cycle to work scheme
  • Costco Wholesale membership
  • WSL – 40% off Will writing service
  • Taste Card