Regulatory Affairs Consultant, Strategy (Full Time)

Job Description

Job Description

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 representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential duties.

Education :

Technical Experience :

Knowledge, Skills, and Abilities :

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 and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment :

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS

We define total rewards as compensation, benefits, remote work / flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere". However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

LEGAL STATEMENT

Syner-G BioPharma Group and Sequoia Biotech Consulting are proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.