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Regulatory Affairs Consultant, Strategy (Full Time)
Posted 23 days agoViewed
💎 Seniority level: Senior, 6+ years
🔍 Industry: Life sciences
🏢 Company: Sequoia Biotech Consulting
🗣️ Languages: English
⏳ Experience: 6+ years
Requirements:
- 6+ years experience 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.
- Strong communication skills, with the ability to mentor, educate, and influence a diverse group of stakeholders.
- Ability to work in a fast-paced, dynamic environment, managing multiple projects and clients while ensuring regulatory compliance and alignment with business goals.
- Experience in supporting and developing strategies and participating in Health Authority interactions.
Responsibilities:
- 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.
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🔥 Regulatory Affairs Consultant, Strategy (Full Time)
Posted 24 days ago
🧭 Full-Time
🔍 Life sciences
🏢 Company: Syner-G
- 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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