Regulatory AffairsMedical Writing Sme

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.
• Assist 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.
• Perform technical reviews of scientific reports, publications, presentations, and clinical documentation to ensure regulatory compliance.
• Interpret applicable laws, regulations, and guidance documents and communicate requirements to research teams.
• Coordinate 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.
• Participate in cross-functional meetings and provide strategic regulatory guidance throughout research and clinical development programs.
• 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.
• Ability to effectively prioritize multiple projects and meet aggressive deadlines.
• Strong interpersonal, written, and verbal communication skills.
• Ability 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.