UK Regulatory Strategy Partner

Roche Holding AG

Welwyn

On-site

GBP 70,000 - 110,000

Full time

8 days ago
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Job summary

Roche Products Ltd in the UK is seeking a Regulatory Partner to join the UK Regulatory Chapter. You will apply your regulatory and scientific expertise to shape strategic initiatives that improve patient access and outcomes.

You will collaborate across functions to translate UK regulatory requirements into Roche policies, lead submissions (Clinical Trial, National Licensing, Early Access) and maintain License to Operate for Roche UK. A strong SME and mentoring mindset is essential.

Qualifications

  • Broad expertise in UK regulatory environment and post-Brexit submissions.
  • Ability to lead strategic regulatory initiatives.
  • Strong cross-functional collaboration with stakeholders.
  • Proven track record in high-quality submissions.

Responsibilities

  • Translate evolving UK requirements into Roche policies and procedures.
  • Lead Clinical Trial Applications and National Licensing submissions.
  • Be Roche UK's primary contact with the MHRA and regulators.
  • Develop and implement squad/chapter regulatory strategies.

Skills

UK Regulatory Affairs
Regulatory strategy
Cross-functional collaboration
Documentation skills

Education

Scientific University degree

Job description

Roche Products Ltd in the UK is seeking a Regulatory Partner to join the UK Regulatory Chapter. You will apply your regulatory and scientific expertise to shape strategic initiatives that improve patient access and outcomes.

You will collaborate across functions to translate UK regulatory requirements into Roche policies, lead submissions (Clinical Trial, National Licensing, Early Access) and maintain License to Operate for Roche UK. A strong SME and mentoring mindset is essential.

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