Regulatory Affairs Consultant, Strategy (Full Time)

COMPANY DESCRIPTION

Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum. 
 
We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale and quality of life-saving innovations.  

We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery, approval, product development, technology transfer and commercial manufacturing process. We also equip our partners with the tools, knowledge and expertise to streamline operations, enhance quality and ensure compliance. 

Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second 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 and Sequoia, 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.Sequoiabiotech.com/ or www.Synergbiopharma.com

 

POSITION OVERVIEW:

The Regulatory Affairs Consultant, Regulatory Strategy, is responsible for guiding clients through regulatory processes, particularly in clinical development and application filings The role coordinates meetings, guides authors, and may serve as primary point of contact with regulatory agencies for clients.  The consultant understands and manages regulatory activities across therapeutic areas and modalities. This position will work cross functionally with CMC technical, QA/Compliance and medical writing teams to enable timely filing and successful development and regulatory approval of life-saving therapeutic agents.

WORK LOCATION:

This position is eligible for remote work based on company requirements, with no minimum in-office requirement. Domestic and international travel may be required for this position (Up to 20%).

JOB FUNCTIONS:

(This list is not exhaustive and may be supplemented and changed as necessary.)

• 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. 

QUALIFICATIONS AND REQUIREMENTS: 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are r