Description:
They are a small, specialised regulatory consulting firm serving biotech, pharmaceutical, and medical device companies. Their mission is to help life sciences organisations navigate complex regulatory requirements and bring ground-breaking products to market. We are seeking a Freelance Regulatory Writer to contribute to their growing portfolio of projects.
Responsibilities:
As a freelance regulatory writer, your key responsibilities will include:
- Writing and reviewing regulatory submission documents (e.g., INDs, NDAs, MAAs, CTDs, briefing documents, and responses to health authorities).
- Preparing clinical and non-clinical documentation (clinical study reports, investigator brochures, protocols, etc.) in compliance with regulatory guidelines.
- Collaborating with cross-functional teams, including regulatory, clinical, and scientific experts, to ensure the accuracy and clarity of submissions.
- Interpreting scientific data and conveying complex information in a concise and compliant manner.
- Ensuring documents adhere to global regulatory standards (FDA, EMA, ICH, etc.) and company/client-specific requirements.
Requirements:
- Proven experience as a regulatory writer in the life sciences sector (biotech, pharma, or medical devices).
- Expertise in regulatory submission processes for major markets (FDA, EMA, or other global agencies).
- Strong ability to write and edit regulatory documents with a high level of accuracy and attention to detail.
- Familiarity with Good Clinical Practice (GCP) and Good Documentation Practice (GDP).
- Degree in life sciences, pharmacy, medicine, or a related field. Advanced degrees or certifications (e.g., RAC) are a plus.
Why Work With Us?:
- Flexible, remote work with competitive freelance rates.
- Opportunity to work on a diverse range of regulatory submissions across multiple therapeutic areas.
- Be part of a close-knit, expert team with a focus on delivering high-quality solutions for our clients.
- Collaborate on cutting-edge life science projects with innovative companies in biotech, pharma, and medical devices.