Manager/Senior Manager (UK), Regulatory Science

Basingstoke, Hampshire (GB)
Competitive
07 Oct 2020
06 Nov 2020
Full Time
Permanent
Management

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.  We seek a Regulatory Science professional to join the United Kingdom (UK) team, with an eagerness to learn and develop, with responsibility for leading Medicines and Healthcare Products Regulatory Agency (MHRA) applications, post-marketing variations, regulatory interactions, and local launch readiness deliverables. A key responsibility will be to help prepare bluebird bio for the UK regulatory environment after full withdrawal from the European Union through intelligence, advice and hands-on know-how. In addition, you will provide ad hoc support for other regional regulatory submissions in the pre- and post-authorisation setting.  Finally, you will spend a part of your time on regulatory intelligence gathering and dissemination. The role will be home-based, with the expectation to travel to bluebird bio’s Basingstoke office 1-2 times a month as required.

 

In this position, you will:

  • Drive the implementation of regulatory guidance in the UK after the end of the Withdrawal Agreement transition period.
  • Act as regulatory submission lead for high quality UK pre- and post-MA submissions in accordance with the Global and European regulatory strategy.
  • Collaborate with regulatory science and cross-functional colleagues on the preparation and submission of regulatory filings, including preparation of major marketing applications, major and routine post-authorisation changes.
  • Participate in regulatory intelligence activities; monitor and inform on regulatory guidelines and trends in Europe and in particular with a view to the UK relationship with the European Union; and participate in UK trade association advocacy activities in coordination with other bluebird bio functions, in particular Regulatory Intelligence.
  • Assist with Clinical Trial Applications to MHRA.
  • In close collaboration with the UK commercial and medical teams, lead the creation and maintenance of local regulatory deliverables, including creation of national prescribing information, review and approval of educational materials, reviewing local artwork, input and review of promotional and non-promotional materials.
  • Support interactions with the MHRA to resolve issues, prepare and submit responses to questions.
  • Prepare submissions plans and manage timelines for regulatory submissions.
  • Prepare and review sections of regulatory submissions to optimise product development (e.g. Orphan Drug, Paediatric Investigation Plans, scientific advice etc.).
  • Manage regulatory documentation and submission logs.
  • Review technical documentation and regulatory documents to ensure conformance with applicable regulatory guidelines, including cell and gene therapy guidelines and internal messaging guidelines and Standard Operating Procedures (SOPs).
  • Develop and maintain SOPs and work instructions (WIs) to ensure processes are in place for UK regulatory requirements
  • Assist the UK team during regulatory agency inspections.

 

About you: 

  • Advanced degree in biochemistry, chemistry, biology, pharmacy, or related pharmaceutical fields including bio-chemical engineering
  • Minimum 5 years of regulatory experience in a biotech/pharma company or consultancy, preferably including biologics/ATMPs
  • In-depth knowledge of current regulations, guidelines (in particular with regards to UK regulatory submissions) and solid understanding of relevant functions developed through experience in the biopharmaceutical industry
  • Experience in rare diseases and/or cell and gene therapies and/or innovative biologics products would be a plus
  • Knowledge of Good Clinical Practice (GCP) and current Good Manufacturing Practices (GMP) preferred
  • Ability to lead cross-functional team/workstream to prepare routine regulatory deliverables and/or submissions to regulatory authorities and successfully implement solutions and best practices
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  • Excellent project management skills, with ability to meet timelines
  • Independently motivated, detail-oriented and good problem-solving ability
  • Excellent organizational skills, able to multi-task in an extremely fast-paced environment with changing priorities
  • Excellent communication skills and ability to influence across multiple functions
  • Be ready to embrace the principles of the bluebird bio culture:  b colourful, b cooperative, and b yourself