Job Details

Regulatory Consultant CMC

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model centers on the customer and the patient. We continually seek to simplify and streamline our work to make Syneos Health easier to work with and for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate therapy delivery because we are passionate about changing lives.

Discover what our 29,000 employees across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people through career development, progression, supportive management, technical and therapeutic training, peer recognition, and total rewards.
• We are committed to our Total Self culture, where you can be yourself. Our culture unites us globally, and we prioritize taking care of our people.
• We aim to build the company everyone wants to work for and with, fostering diversity of thoughts, backgrounds, cultures, and perspectives to create an inclusive environment.

Job Responsibilities

For non-complex and complex submissions, independently fulfill responsibilities such as:

• Research existing product data related to global or regional regulatory requirements for gap analyses, product development plans, and submissions.
• Contribute to or prepare regulatory agency submission components for INDs, pre-approval packages, product registration, and post-approval maintenance. Prepare briefing packages and support agency interactions.
• Manage daily regulatory activities for assigned projects, ensuring adherence to timelines, scope, budgets, and strategies.
• Participate as regulatory support on multidisciplinary project teams, including clinical and technical experts, throughout product lifecycle.
• Act as a subject matter expert, assisting team members with troubleshooting and presenting solutions.
• Prepare estimates for regulatory services in proposals.
• Support meetings with clients regarding proposals, project status, and business development.
• Ensure compliance with global regulatory requirements and company policies.
• Develop training materials and share best practices internally and externally.
• Support internal and external audits and cross-functional initiatives.
• Contribute to SOP and process documentation.
• Oversee team members' project responsibilities and provide guidance.
• Maintain individual training records and complete required training.

At Syneos Health, we foster an environment where our people can thrive, develop, and progress. We offer benefits like a company car or allowance, health benefits, 401k matching, stock purchase plans, performance bonuses, and flexible PTO. Eligibility for some benefits varies by location.

Salary Range: $56,400 - $95,900

Actual salary depends on qualifications, skills, and proficiency.

Get to know Syneos Health

Over the past 5 years, we've worked with 94% of all FDA-approved drugs, 95% of EMA-authorized products, and conducted over 200 studies across 73,000 sites with 675,000+ trial patients.

Join us to challenge the status quo in a dynamic environment. Learn more at

Additional Information

Tasks listed are not exhaustive. The company may assign other duties at its discretion. Qualifications may be considered equivalent, and nothing herein should be construed as a contract. We comply with all applicable laws and regulations, including the ADA, and provide reasonable accommodations as needed.