Regulatory Affairs

OpenKrill; United States; Remote; USD 180,000 - 250,000; Full time

Benefits offered by this job

Equity

Job summary

Edison Scientific is seeking a Regulatory Affairs/Medical Writer to join our Forward Deployed team on site with pharma and biotech partners. You will evaluate AI-assisted content, set benchmarks for quality, and coordinate with partner regulatory and medical writing teams to ensure submissions meet guidelines and standards.

You will guide the regulatory content integrity of AI outputs, understand agency expectations, and feed insights back to improve platform reasoning for regulatory documents

Qualifications

• 5+ years in Regulatory Affairs or Medical Writing in pharma/biotech
• Bachelor's degree required; advanced degree preferred (Ph.D./Pharm.D./M.D./M.S.)
• Familiarity with ICH guidelines and FDA/EMA expectations
• Experience authoring CTD modules, clinical study reports, investigator brochures, and briefing documents
• Experience with eCTD structure and end-to-end submission process (IND to NDA/BLA/MAA)
• Travel 20-40% of time

Responsibilities

• Evaluate and improve AI-generated regulatory and medical writing tasks (IND/NDA modules, clinical study reports, IBDs, briefing documents)
• Partner with client regulators and medical writers to ensure quality, accuracy and compliance for submissions
• Build benchmarks and acceptance criteria for regulatory writing-focused AI workflows
• Collaborate with regulatory professionals to deploy AI agents in document preparation workflows
• Act as regulatory content authority on AI outputs, assessing accuracy, compliance, and narrative quality
• Work with Forward Deployed Engineers to scope engagements and measure success

Skills

Regulatory Affairs

Medical Writing

ICH Guidelines

FDA/EMA standards

eCTD knowledge

Education

Bachelor's degree

Ph.D./Pharm.D./MD/MS preferred

Tools

Veeva Vault

Documentum

Job description

ABOUT US

Edison Scientific builds and deploys AI scientist agents to accelerate science and the development of new medicines. We are an ambitious team run by scientists and engineers from leading institutions across biology, physics, chemistry, and AI.

ABOUT THE ROLE

We are looking for a Regulatory Affairs/Medical Writer to join our Forward Deployed team. In this role, you will be working onsite with pharma and biotech partners alongside our engineers. You'll evaluate agent drafted content, build benchmarks to measure quality, and work with our partners' regulatory and medical writing teams to find where AI can meaningfully accelerate document preparation across the submission lifecycle. You bring the regulatory judgment that determines whether AI generated text is submission ready or needs rework.

This is embedded, partner facing work. You'll build credibility with regulatory and clinical teams, understand their writing conventions and agency expectations, and feed insights back to our AI team to improve how our platform reasons about regulatory content, structure, and scientific argumentation.

KEY RESPONSIBILITIES

• Evaluate and improve AI agent performance on regulatory and medical writing tasks including IND and NDA module drafting, clinical study reports, investigator brochures, briefing documents, and response to agency queries
• Partner with end users at client organizations to validate that our AI generated regulatory documents meet the quality, accuracy, and compliance bar required for health authority submissions
• Build benchmarks and acceptance criteria for regulatory writing focused agent workflows
• Work directly with regulatory affairs professionals and medical writers at partner organizations to deploy AI agents into their document preparation workflows
• Act as the regulatory content authority on AI generated outputs, assessing scientific accuracy, guideline compliance, internal consistency, and narrative quality
• Collaborate daily with Forward Deployed Engineers on each account and support engagement scoping, success metrics, and technical evaluation with the Go-to-Market team.

REQUIRED QUALIFICATIONS

• 5+ years of experience in Regulatory Affairs or Medical Writing within the pharmaceutical or biotechnology industry, ideally within a sponsor organization
• Bachelor's degree required; advanced degree preferred (Ph.D., Pharm.D., M.D., or M.S. in a life sciences discipline)
• Strong understanding of regulatory requirements and familiarity with ICH guidelines and FDA/EMA expectations
• Hands on experience authoring regulatory documents such as CTD module sections, clinical study reports, investigator brochures, and briefing documents, with exposure across IND through commercial submissions (NDA, BLA, MAA)
• Familiarity with eCTD structure and the end to end submission process from authoring through publishing
• Experience in therapeutic areas such as oncology, immuno-oncology, immunology, cardiovascular, neurology, or hepatology (MASH) preferred
• Experience with regulatory information management systems such as Veeva Vault or Documentum
• Ability to travel 20-40% of the time

PREFERRED QUALIFICATIONS

• Familiarity with AI assisted writing or document automation tools
• High comfort with ambiguity and fast iteration

SALARY

$180,000 - $250,000

Offers equity

WHY JOIN US?

• Competitive salary and equity
• Full healthcare coverage; we pay 100% of premiums for you and your dependents
• Support for growing families, including a yearly new parent stipend and fertility coverage through Carrot
• Mental health support through Rula, our in-network therapist and psychiatrist network with fast availability
• 12 weeks of paid parental leave for maternity, paternity, and adoption
• Pet care support with a yearly employer-funded stipend for your animal companions
• Commuter benefits so you can pay for transit and parking with pre-tax dollars
• 401(k) company matching
• $300 health and wellness benefit quarterly
• Lunch is on us every day you're in the office, and dinner is on us when you're working late
• Regular team off-sites and company events

Edison Scientific is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.