Regulatory Affairs (FDA) SME

SyncIQ helps life sciences teams work faster and stay compliant using our product. Our platform brings together specialized product “agents” that automate routine tasks and support complex, review-heavy work in areas like Regulatory Affairs, Quality/GMP, Market Access, and Medical Affairs. We focus on quick, safe adoption and integrate with the products teams already use.

Location: Remote

Type: Full-time

We’re hiring a Regulatory Affairs SME to help design and validate how our product supports regulatory work. You will review product outputs for accuracy, design clear workflows, and make sure our products follow the right guidelines (FDA, ICH, and 21 CFR). You’ll work closely with product, engineering, data science, and quality teams.

• Validate product outputs: Review, challenge, and approve product-generated regulatory content (for example: dossier checks, labeling proposals, and drafts for IR/483/CRL responses) to ensure scientific accuracy, traceability, and alignment with FDA/ICH expectations.
• Help design regulatory workflows: Outline step-by-step processes for preparing submissions, creating labeling, and engaging with agencies. Identify what information is needed at each stage, when reviews or approvals should happen, and where people need to be directly involved. Set clear standards for what “done” looks like. Turn regulations into easy-to-follow guidance, prompts, and guardrails for the team.
• Apply the right guidelines: Translate regulatory guidance into clear rules and checks within our processes. Make sure these rules stay current as FDA, ICH, and 21 CFR requirements evolve.
• Documentation & traceability: Maintain templates, checklists, and traceability matrices that link requirements to tests and evidence. Support UAT and release readiness.
• Cross‑functional collaboration: Partner with Product, Engineering, Data Science, Quality, and client SMEs to iterate quickly and close validation findings.
  

• M. Pharm in Regulatory Affairs or 3–4 years of experience working in the regulatory domain (pharmaceutical industry).
• Hands-on experience with multiple ANDA submissions.
• Familiarity with FDA and ICH frameworks and evidence requirements.
• Strong communication skills and attention to detail.
• Nice to have: experience using AI tools such as ChatGPT, Gemini, or similar to support regulatory workflows.
  

• Work on real regulatory problems with cutting-edge products.
• Collaborate with experienced RA, Quality, Product, and Data Science teams.
• Remote‑first culture with a focus on impact, speed, and quality.