Regulatory Writer

3 weeks ago


Manchester, United Kingdom Vivify Talent Limited Full time

At Vivify Talent Limited, we are seeking a skilled Principal Regulatory Writer to join our team. As a leading medical communications agency, we are committed to excellence in pharmaceutical communications and are expanding our regulatory department.

About the Role

The successful candidate will play a pivotal role in translating complex scientific and clinical data into compelling regulatory documents, ensuring compliance with European regulations and industry standards.

Key Responsibilities
  • Develop high-quality regulatory documents, including clinical study reports, regulatory submissions, protocols, investigator brochures, and marketing authorization applications.
  • Stay up-to-date with industry advancements and regulatory updates to maintain the highest standards of technical accuracy.
  • Collaborate effectively with cross-functional sponsor teams, bridging the gap between regulatory affairs, clinical teams, and other stakeholders.
Requirements
  • Bachelor's degree in a relevant scientific discipline.
  • Proven experience in regulatory writing, with a focus on European regulations.
  • Strong technical acumen with the ability to comprehend and articulate complex scientific and clinical information.
Benefits
  • A competitive compensation package reflecting your skills and expertise.
  • The opportunity for professional growth within a thriving SME environment.
  • Flexible working arrangements to accommodate your unique work style.

The estimated salary for this position is £55,000 - £65,000 per annum, depending on experience.



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