Quality , Science, Pharmaceutical & Food

Senior Regulatory Policy Officer

  • Contract
  • Remote
  • Southern England
  • 41931810

PE Global is currently recruiting for a Senior  Regulatory Policy Officer for a leading multi-national biotech client based in London (Hybrid)


This is a 23 month contract and there is the option to work on a hybrid basis for the right candidate.


This position is primarily intended to support the EU R&D and Regulatory Policy lead in executing the team priorities. The candidate must be able to effectively track and analyze EU regulatory policy issues that could impact the client’s approved products and pipeline candidates, and all involved modalities and disease areas. The individual will work cross-functionally especially in collaboration with EU Regulatory Affairs and EU Government Affairs.

Broader support to other members of the R&D and Regulatory Policy team and project management support related to the functioning of the team itself will also be required, in particular for all ex-US regions including EMEA, APAC and LATAM.


Role:

Support the EU Reg Policy lead in the following activities:

  • Monitoring, reviewing and informing stakeholders on recently published EU regulatory policies and guidance documents impacting development of treatments for rare diseases and advanced therapies in particular.
  • Contributing as needed to all types of internal reporting (ad hoc memos, weekly summaries, highlights, digests etc.)
  • If required, representing the client on trade association calls and meetings, and generate minutes for the benefit of the EU lead.
  • If required, attending external scientific and regulatory conferences, typically virtually, ensuring key intelligence and highlights are shared with the EU lead and the rest of the organization.
  • Supporting the preparation and follow-up of internal meetings with stakeholders and SMEs.
  • Updating the team’s trackers, engagement maps and SharePoint.
  • Monitoring and documenting progression of the EU objectives and key results (OKRs).

In addition, support the Global R&D and Regulatory Policy Team in the following regulatory policy activities:

  • Provide project management support to the policy team in generation of comments on draft guidances.
  • Track Team memberships and involvement in policy trade associations and organizations.
  • Actively monitor and track policy meetings, track policy team activities and reports, track relevant policies and regulations.
  • Lead certain policy cross-functional meetings including minutes and action items.
  • Provide strategic logistical support for managing policy calendars and deliverables.
  • Develop and manage internal policy publications.
  • Develop and manage dashboards for policy team initiatives.
  • Develop, track and manage regulatory conferences and inform internal stakeholders of such conferences.
  • Manage global policy deliverables, workload tracking, policy tracker, and SharePoint archival system.
  • Manage Trade Association List and Memberships including main contacts.


Requirements:

  • Bachelor’s or Master’s degree in biology or other life sciences discipline
  • Project Management Professional would be helpful
  • Thorough understanding of the EU regulatory environment is a requirement.
  • EMA/EU regulatory agency experience, or experience in an EU trade organization, ideal but not an absolute prerequisite
  • At least 3 years’ work experience in regulatory policy, or project or program management; a minimum of two years’ experience managing teams and team operations desired.
  • Pharma/biotech industry experience required, including at least 1 year in Regulatory Affairs and/or policy.
  • Experience with MS Office and MS Project Online, or similar scheduling software, required or proven skill at adapting to new software/technology.
  • Exposure to electronic document management system(s) (EDMS) and registration tracking systems helpful.
  • The candidate should possess the ability to work as part of international and interdisciplinary teams, have strong organizational skills, excellent interpersonal and communication (written and verbal) skills and understanding of biotech/pharmaceutical industry and nomenclature.
  • Strong attention to detail


Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to Jennifer.horgan@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

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