Position: Regulatory Affairs Specialist

Type: Contract

Compensation: $50 - $70/hour

Location: Remote

Commitment: 10-40 hrs/week

Role Responsibilities

- Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads.
- Apply expert judgment to review clinical documentation for regulatory compliance.
- Distinguish between substantively adequate and superficially polished responses.
- Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims.
- Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines.
- Collaborate asynchronously and communicate complex regulatory concepts clearly.

Requirements

- Have robust relevant experience in the domain of regulatory affairs.




- Documented experience drafting or leading responses to health authority information requests.
- Demonstrated working knowledge of the ICH framework and CTD/eCTD structure.
- Proven ability to critically read clinical or safety documents to identify regulatory risks.
- Exceptional written communication skills with the capability to convey regulatory reasoning clearly.
- Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.

Application Process

- Easy Apply on LinkedIn
- Check email for next steps
- Participate in resume evaluation & interview stage

📌 Regulatory Affairs Specialist | $70/hr Remote (Canada)
🏢 Crossing Hurdles
📍 Canada