Syner-G
PrincipalRegulatoryAffairsConsultant
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“Principal Regulatory Affairs Consultant at Syner-G. Skills: Regulatory affairs, Drug approval process, Regulatory submissions. Oversee preparation, review, and submission of Non-Clinical/Clinical regulatory. Handle FDA Type A, Type B, and Type”
What You'll Achieve.
Accelerate breakthrough science; Deliver life-enhancing therapies; Successful development of pharmaceutical products; Successful approval of pharmaceutical products; Optimize pathways for drug submissions; Ensure compliance
Industry & Context.
Solutions-driven approach
Travel to client sites may be required
What They're Looking For.
Must Have
Bachelor’s degree in chemistry, pharmaceutics, biology, or related scientific field, Experience in handling INDs, NDAs, BLAs, Experience in handling global submissions, Experience in authoring and managing Non-Clinical/Clinical Medical Device and FDA sections for regulatory submissions, Ability to evaluate manufacturing and quality changes for regulatory impact, Proficient in Microsoft Office Suite, Proficient in industry-specific software tools such as Trackwise, Veeva, and ICTD
Nice to Have
MA degree preferred, RAC Certification or extensive experience in regulatory affairs
What You'll Do.
and submission of Non-Clinical/Clinical regulatory
Engage in all phases of drug development
Develop regulatory documents
Review regulatory documents
Author NDA submissions
Author BLA submissions
Coordinate with Non-Clinical/Clinical teams
Assist clients with Non-Clinical/Clinical strategy
Draft submission documents
Review content for completeness
Review content for editorial quality
Manage global forms and documents submission
Submit global forms and documents
Ensure compliance with international guidelines
Ensure compliance with regional guidelines
Lead meetings with FDA representatives
Prepare briefing documents
Guide clients through regulatory requirements
Provide regulatory advice
Support marketing initiatives
Serve as main point of contact for clients
Ensure effective communication
Ensure regulatory support
Facilitate development of Non-Clinical/Clinical documentation
Facilitate review of Non-Clinical/Clinical documentation
Facilitate resolution of comments on Non-Clinical/Clinical documentation
Partner with clients on Non-Clinical/Clinical strategy
Partner with clients on submissions
Evaluate proposed manufacturing changes for impact
Evaluate proposed quality changes for impact
Manage regulatory communications for Non-Clinical/Clinical issues
Lead project management activities for ValGenesis implementation
Lead project management activities for Kneat implementation
Conduct analysis of client validation processes
Document user requirements
Document functional specifications
Document system requirements
Document workflow needs
Plan stakeholder workshops
Facilitate stakeholder workshops
Plan discovery sessions
Facilitate discovery sessions
Plan Conference Room Pilots
Facilitate Conference Room Pilots
Assess current-state validation processes
Define future-state solutions
Configure ValGenesis software
Configure Kneat software
Develop business requirements
Develop configuration documents
Develop related documentation
Partner with Quality stakeholders
Partner with Validation stakeholders
Partner with IT stakeholders
Partner with Engineering stakeholders
Partner with Manufacturing stakeholders
Ensure alignment on system validation
How You'll Work.
Team & Collaboration
Client sites; Non-Clinical/Clinical teams; Quality stakeholders; Validation stakeholders; IT stakeholders; Engineering stakeholders; Manufacturing stakeholders
Communication Scope
Client communication; Regulatory communications
Process & Methodology
Project management
Full Job Description
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com POSITION OVERVIEW: As a Senior General Strategy Consultant, you will play a pivotal role in guiding clients through the complex landscape of regulatory affairs, ensuring comp
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