Consultant II

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 Consultant II (Clinical Strategy), you will play a pivotal role in guiding clients through the complex landscape of regulatory affairs, ensuring compliance and facilitating the successful development and approval of pharmaceutical products. You will serve as a strategic partner, leveraging your expertise to navigate regulatory requirements and optimize pathways for drug submissions, focusing on clinical development activities from early stage development to late stage planning. KEY RESPONSIBILITIES :   (This list is not exhaustive and may be supplemented and changed as necessary.)  Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents for various clients. Handle FDA Type A, Type B, Type C and Type D meetings. Engage in all phases of drug development, from early-stage to post-registration. Develop and review regulatory documents, author IND, NDA and BLA submissions, and coordinate with Non-Clinical/Clinical teams. Assist clients with Non-Clinical and Clinical strategy and clinical development activities and design, 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. 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. Manage regulatory communications for Non-Clinical/Clinical issues with the FDA and other global regulatory authorities. QUALIFICATIONS AND REQUIREMENTS :   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.  Education :   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. Technical Experience :   Proficient in Microsoft Office Suite and industry-specific software tools such as Trackwise, Veeva, and ICTD. Strong understanding of drug development, manufacturing, and clinical development processes. Experience in authoring and managing Non-Clinical/Clinical and FDA sections for regulatory submissions. Ability to evaluate manufacturing and quality changes for regulatory impact. Demonstrated proficiency in regulatory information management systems and tools Familiarity with the ICH Common Technical Document (CTD) structure and ability to author sections within this framework. Experience with protocol development.  Knowledge, Skills, and Abilities :   Strong background in drug development, biologics, and clinical trials. Proven experience in handling INDs, NDAs, BLAs, and global submissions. Demonstrated ability to adapt to client needs, providing strategic advice and tactical support across various therapeutic areas. ESSENTIAL FUNCTIONS :   Physical Demands :   The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to use a computer keyboard