Principal Regulatory Affairs Consultant

Job not on LinkedIn

🕒 June 2

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

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Syner-G BioPharma Group

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syner-G BioPharma Group is the world's leading provider of chemistry, manufacturing and controls (CMC), regulatory affairs, and medical writing solutions for the biopharma sector. They offer comprehensive services that navigate clients through the complexities of pharmaceutical development, regulatory submissions, and quality compliance, ensuring high-quality outcomes. With a multidisciplinary team, Syner-G integrates science, engineering, and regulatory expertise to support drug development from pre-IND to post-approval phases, enabling timely submissions and patient safety adherence.

📋 Description

• Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents for various clients. • Handle FDA Type A, Type B, and Type C meetings. • Engage in all phases of drug development, from early-stage to post-registration. • Develop and review regulatory documents, author NDA and BLA submissions, and coordinate with Non-Clinical/Clinical teams. • Assist clients with Non-Clinical/Clinical strategy, draft submission documents, and review content for completeness and editorial quality. • Manage and submit forms and documents globally, ensuring compliance with international and regional guidelines. • Lead meetings with FDA representatives, prepare briefing documents, and guide clients through regulatory requirements. • Conduct research, provide regulatory advice, and support marketing initiatives through blogs, white papers, and industry engagement. • Serve as the main point of contact for clients, ensuring effective communication and regulatory support. • Mentor and train new employees in regulatory affairs, Non-Clinical/Clinical, and FDA processes. • Facilitate the development, review, and resolution of comments on technically complex Non-Clinical/Clinical documentation for regulatory submissions. • Partner with clients on Non-Clinical/Clinical strategy and submissions. • Evaluate proposed manufacturing and quality changes for impact on existing registrations. • Manage regulatory communications for Non-Clinical/Clinical issues with the FDA and other global regulatory authorities.

🎯 Requirements

• Bachelor’s degree in chemistry, pharmaceutics, biology, or a related scientific discipline; MA degree preferred. • RAC Certification is a significant advantage; equivalent certifications or extensive experience in regulatory affairs are highly valued.

🏖️ Benefits

• flexible paid time off • company-paid holidays • flexible working hours • remote work options for most roles