Regulatory AffairsMedical Writing Sme

Position Summary

Axle is seeking a Senior Medical Writer & Regulatory Affairs Consultant to support the National Institutes of Health (NIH) Blueprint Neurotherapeutics Network (BPN). This role provides scientific leadership and regulatory expertise throughout the drug discovery and development process by preparing, reviewing, and coordinating regulatory submissions while ensuring compliance with FDA regulations, ICH guidelines, and industry best practices.

The successful candidate will collaborate with multidisciplinary scientific teams to develop high-quality regulatory documentation, provide strategic regulatory guidance, and support the successful advancement of therapeutic development programs.

Responsibilities

• Serve as the medical writing and regulatory affairs subject matter expert on NIH Blueprint Neurotherapeutics Network (BPN) Lead Development Teams.
• Prepare, edit, review, and coordinate regulatory submissions, including:
• Investigational New Drug (IND) applications
• IND amendments
• Investigator Brochures (IBs)
• Clinical protocols
• Drug Master Files (DMFs)
• FDA Form 1572 and related regulatory documentation
• Ensure regulatory documents are scientifically accurate, complete, and compliant with FDA regulations and ICH guidelines.
• Advise investigators and project teams on regulatory strategy throughout the drug development lifecycle.
• Affiliate with researchers in obtaining and maintaining regulatory approvals for drugs, biologics, medical devices, and related healthcare products.
• Manage regulatory documentation, submission timelines, and document repositories in accordance with regulatory requirements.
• Develop templates, standard operating procedures (SOPs), and internal guidance documents to support regulatory compliance.
• Conduct regulatory research to monitor emerging regulations, guidance documents, and industry trends.
• Interpret applicable laws, regulations, and guidance documents and communicate requirements to research teams.
• Cook up communications with regulatory agencies regarding submissions, regulatory strategies, and requests for clarification.
• Manage internal regulatory activities including audits, inspections, registrations, and compliance reviews.
• Develop remediation plans and corrective actions based on internal compliance assessments.
• Collaborate with scientists, clinicians, medical writers, and data scientists to improve regulatory processes and documentation systems.
• Support continuous improvement initiatives by identifying opportunities to enhance regulatory processes and documentation quality.

Required Qualifications

• Master's degree or Ph.D. in a scientific discipline.
• Minimum of 10 years of medical writing and regulatory affairs experience within the pharmaceutical, biotechnology, or CRO industry.
• Extensive experience preparing, reviewing, and managing FDA regulatory submissions, including INDs, Investigator Brochures, clinical protocols, and related regulatory documentation.
• Strong knowledge of FDA regulations, ICH guidelines, Good Clinical Practice (GCP), and the drug development process.
• Experience with Electronic Common Technical Document (eCTD) submissions.
• Excellent scientific writing, editing, and document management skills.
• Able to effectively prioritize multiple projects and meet aggressive deadlines.
• Strong interpersonal, written, and verbal communication skills.
• Able to work independently and collaboratively within multidisciplinary and virtual teams.

Preferred Qualifications

• Experience overseeing regulatory document preparation performed by external organizations.
• Experience supporting NIH-funded research programs or academic medical research.
• Familiarity with regulatory database management systems and electronic document management platforms.
• Experience developing regulatory policies, SOPs, and compliance programs.
• Demonstrated ability to lead cross-functional regulatory initiatives.

Salary Range

$90,000 USD - $98,000 USD