Syner-G
SeniorClinicalStrategyConsultant
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“Senior Clinical Strategy Consultant at Syner-G. Skills: Clinical strategy, Regulatory affairs, Drug development, FDA meetings. Oversee preparation of regulatory documents. Oversee review of regulatory documents”
What You'll Achieve.
Accelerate breakthrough science; Deliver life-enhancing therapies
Industry & Context.
Lift and carry objects up to 25 pounds
What They're Looking For.
Must Have
Bachelor's degree in chemistry, pharmaceutics, biology, or related scientific field, Proficient in Microsoft Office Suite, Proficient in industry-specific software tools, Understanding of drug development, Understanding of manufacturing, Understanding of clinical development processes, Experience in authoring regulatory submissions, Experience managing regulatory submissions, Ability to evaluate manufacturing changes for regulatory impact, Ability to evaluate quality changes for regulatory impact, Demonstrated proficiency in regulatory information management systems, Demonstrated proficiency in regulatory information management tools, Familiarity with ICH CTD structure, Ability to author sections within CTD framework, Background in drug development, Background in biologics, Background in clinical trials, Proven experience handling INDs, Proven experience handling NDAs, Proven experience handling BLAs, Proven experience handling global submissions, Ability to adapt to client needs, Ability to provide strategic advice, Ability to provide tactical support, Regularly use computer keyboard, Regularly reach with hands, Regularly talk, Regularly listen, Frequently walk, Frequently sit, Lift and carry objects up to 25 pounds, Occasionally stand, Occasionally stoop, Occasionally kneel, Close vision, Ability to adjust focus
Nice to Have
MA degree preferred, RAC Certification preferred, Extensive experience in regulatory affairs preferred
What You'll Do.
Oversee preparation of regulatory documents
Oversee review of regulatory documents
Oversee submission of regulatory documents
Handle FDA Type A meetings
Handle FDA Type B meetings
Handle FDA Type C meetings
Handle FDA Type D meetings
Engage in drug development phases
Develop regulatory documents
Review regulatory documents
Author IND submissions
Author NDA submissions
Author BLA submissions
Coordinate with Non-Clinical teams
Coordinate with Clinical teams
Assist clients with Non-Clinical strategy
Assist clients with Clinical strategy
Assist clients with clinical development activities
Design submission documents
Draft submission documents
Review submission document content
Manage global documents
Submit global documents
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 documentation
Facilitate review of documentation
Facilitate resolution of comments on documentation
Partner with clients on Non-Clinical strategy
Partner with clients on Clinical strategy
Partner with clients on submissions
Manage regulatory communications for Non-Clinical issues
Manage regulatory communications for Clinical issues
Manage regulatory communications with FDA
Manage regulatory communications with global regulatory authorities
How You'll Work.
Team & Collaboration
Coordinate with Non-Clinical teams; Coordinate with Clinical teams
Communication Scope
Client communication; Regulatory communication
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 Clinical Strategy Consultant, you will play a pivotal role in guiding clients through the complex landscape of regulatory affairs, ensuring com
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