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🔥 Regulatory Affairs Consultant, Strategy (Full Time)
Posted 24 days ago

🧭 Full-Time

🔍 Life sciences

  • Experience (6+ years) in regulatory affairs, including agency interactions, submission and project management and regulatory planning.
  • Experience in supporting teams in filing of INDs/CTAs and NDAs/BLA/MAAs
  • Expertise across all phases of drug development, including biologics, pharmaceuticals, oncology, orphan drugs, and pediatric studies.
  • Industry experience and adept teamwork skills to navigate diverse backgrounds effectively.
  • Strong research skills to stay current with changing regulations and locate relevant resources.
  • Knowledge of FDA regulations, international guidelines, and the ability to advise on fast-track analysis, pediatric studies, and emergency inquiries. Proficiency in Microsoft Office applications, particularly Excel and PowerPoint.
  • Guide clients on decisions, agency meetings, and regulatory filings, with emphasis on clinical development.
  • Oversee INDs, CTAs, application filings, and approvals for various clients, including significant applications for clinical supplies and trials.
  • Handle FDA meetings, prepare clients, resolve questions, and develop/execute data driven strategies.
  • Engage in multiple phases of drug development, from early-stage to post-registration, ensuring client needs are met.
  • Develop and review regulatory documents, authoring NDA, BLA submissions, and coordinating with medical writing, CMC, quality, nonclinical, and technical teams.
  • Manage and submit forms and documents globally, ensuring compliance with international and regional guidelines.
  • Lead meetings with FDA representatives, prepare briefing documents, and assist clients in navigating regulatory requirements.
  • Conduct research, provide regulatory advice, and support marketing initiatives through blogs, white papers, and industry engagement.
  • Mentor and train new employees, providing guidance on systems, software, and regulatory processes.
  • Collaborate across departments and with client teams, ensuring alignment on project goals and regulatory strategies.
  • Maintain continuous education on regulatory updates and new releases, contributing to team knowledge and industry best practices.
Posted 24 days ago
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🔥 Senior Regulatory Affairs Specialist
Posted 3 months ago

📍 United States, India

🔍 Life sciences consulting

  • A Bachelor’s degree in a health or life science discipline is required; advanced degree preferred.
  • 5+ years of experience in the pharmaceutical industry in research, manufacturing, analytical, or quality.
  • 2+ years of experience in Regulatory-CMC.
  • Ability to read and interpret technical documents and health authority regulations.
  • Familiar with Common Technical Document (CTD) formatting and working knowledge of US and European regulations.
  • Author and review high-quality, compliant CMC regulatory documents (e.g., Core Dossiers, INDs, CTAs, MAAs, BLAs, Variations and other relevant regulatory CMC filings).
  • Perform assessment of CMC changes and identify global regulatory requirements.
  • Compile documentation for regulatory submission packages including license renewals and market registration.
  • Ensure compliance with FDA, EMA, and global regulatory requirements.
  • Work with multiple regulatory systems and tools during the end-to-end submission process.
Posted 3 months ago
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