Posted over 30 days ago. Roles like this often stay open for a while, so it's still worth applying.
Regulatory Affairs Specialist at micro1
posted 3 months agoRegulatory Affairs Specialist | $50–70/hr | Worldwide Remote
We are seeking an experienced Regulatory Affairs Specialist to support regulatory submissions and clinical documentation review within the medical domain. This is a fully remote contractor role ideal for a detail-oriented professional with a strong background in ICH guidelines and CTD/eCTD structure.
Key Responsibilities
- Prepare, review, and manage regulatory submissions in compliance with applicable guidelines
- Review and evaluate clinical documentation for accuracy, completeness, and regulatory compliance
- Apply ICH guidelines and CTD/eCTD formatting standards to submission packages
- Liaise with health authorities and support interactions throughout the review process
- Collaborate effectively with cross-functional remote teams to meet submission timelines
- Apply critical thinking to identify and resolve regulatory issues proactively
Required Skills & Experience
- Proven experience in regulatory affairs within the medical or pharmaceutical sector
- Strong knowledge of ICH guidelines and CTD/eCTD structure
- Experience with clinical documentation review and regulatory submissions
- Excellent written communication skills for preparing clear regulatory documents
- Strong attention to detail and critical thinking abilities
- Comfortable working in a fully remote, collaborative environment
This is a contractor engagement offering competitive hourly compensation between $50 and $70 per hour, depending on experience and qualifications.