Principal Regulatory Affairs Consultant

Syner-G BioPharma Group

Senior General Strategy Consultant guiding clients through complex regulatory affairs for pharmaceutical development. Serving as a strategic partner with expertise in compliance and approvals.

Posted 6/2/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory document preparationNDA submissionsBLA submissionsregulatory strategy developmentregulatory complianceregulatory communicationsclinical trial documentationresearch and analysiseditorial quality reviewsubmission document drafting

Soft Skills

effective communicationmentoringclient managementleadershipteam collaborationproblem-solvingorganizational skillstrainingadvisory skillsmeeting facilitation

Certifications

RAC CertificationBachelor’s degree in chemistryBachelor’s degree in pharmaceuticsBachelor’s degree in biologyMA degree in related scientific discipline