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Regulatory Content Specialist
2 months ago
We are a dynamic and growing medical communications agency committed to excellence in pharmaceutical communications.
About Us:
We provide high-quality regulatory content services that meet the stringent requirements of the European regulatory landscape. As we expand our regulatory department, we are seeking a talented and experienced Principal Regulatory Writer to join our team. This role is ideal for an individual who is passionate about translating complex scientific data into compelling regulatory documents while ensuring compliance with European regulations and industry standards.
Role Overview:
As a Principal Regulatory Writer, you will play a pivotal role in developing high-quality regulatory documents, including clinical study reports, regulatory submissions, protocols, investigator brochures, and marketing authorization applications. Your expertise in European regulations will be crucial in ensuring compliance and technical accuracy. We value your ability to work collaboratively with cross-functional sponsor teams and effectively communicate complex information to various stakeholders.
Key Responsibilities:
- Leverage your in-depth knowledge of European regulations to contribute to the development of high-quality regulatory documents.
- Demonstrate a keen ability to synthesize and present scientific and clinical data accurately and coherently.
- Stay abreast of industry advancements and regulatory updates to ensure the highest standards of technical accuracy.
- Work collaboratively with cross-functional sponsor teams, bridging the gap between regulatory affairs, clinical teams, and other stakeholders.
Remote Accessibility:
Embrace the opportunity to work remotely, allowing you to cultivate a conducive work environment that optimizes your productivity and work-life balance. We offer part-time and full-time vacancies, giving you the flexibility to choose the arrangement that suits you best.
Qualifications and Experience:
Bachelor's degree in a relevant scientific discipline such as life sciences, chemistry or biology.
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. You should be well-versed in ICH-GCP, EU GMP, EU Medical Device Regulation, and related guidelines. Benefits:
Competitive compensation package reflective of your skills and expertise, estimated at £60,000 - £80,000 per year depending on qualifications and location.
Opportunity for professional growth within a thriving SME environment.
Flexible working arrangements to accommodate your unique work style.
