Regulatory Affairs Specialist for Global Acceleration

1 week ago


Uxbridge, United Kingdom Lifelancer Full time
Job Summary

We are seeking a highly experienced Regulatory Affairs specialist to join our team in support of a global acceleration client initiative. This exciting opportunity will see you play a crucial role in accelerating time to filing and approval in various markets.

About the Role

This is an excellent chance to work with a dynamic team on a mission to accelerate the time for submission, approvals, and accessing markets. As a Regulatory Affairs specialist, your key responsibilities will include:

  • Developing and implementing global regulatory strategies for simultaneous marketing authorisation submissions
  • Identifying risks and mitigations to protect business interests and maintain timelines
  • Leading detailed preparation of regulatory plans for individual country filings
  • Leading global filing teams in generating country-specific datasets and updating core documentation
  • Adapting core dossier contents for country submissions
  • Coordinating filing teams for RTQ generation, providing strategic guidance to address regulators' questions and guiding the team to prepare high-quality responses
  • Suggesting and coordinating innovative regulatory procedures to increase acceleration opportunities
  • Working closely with local and regional regulatory leads on all aspects of marketing review and approvals
Requirements and Qualifications

To be successful in this role, you will need to have a strong background in life sciences and at least 8-15 years of relevant regulatory affairs experience. You should also have extensive experience in preparing global filing plans for markets worldwide and awareness of regulatory frameworks in all major markets globally.

A university degree in life science is required, as well as proficiency in Veeva Vault and other regulatory systems. Strong leadership skills and excellent communication and organizational abilities are also essential. Experience working within a regulatory matrix team in the pharmaceutical industry is desirable, as is fluency in English.

Compensation Package

The estimated salary for this position is between $120,000 - $180,000 per annum, depending on location and experience. Benefits include competitive healthcare insurance, retirement plan options, and professional development opportunities.



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