Regulatory Consultant, ROW Market Experience, CMC – Module 3 Experience

Syneos Health

Regulatory Consultant managing regulatory submissions in ROW markets and CMC for Syneos Health. Collaborating with cross-functional teams and acting as a subject matter expert for submissions.

Posted 5/8/2026full-time🇺🇸 United StatesMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance.
Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions.
Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.
Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
Act as a subject matter expert and help the team members with day-to-day troubleshooting activities, presenting solutions to project related problems.
Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.

Requirements

What you’ll need

Candidate should have ROW markets exp and CMC – Module 3
Should have Post‑approval variations and responding to Health Authority Questions (RTQs) exp
Should have API & Drug Product variations exp and site transfer exp.
Ability to work independently and collaborate with cross-functional teams
Should have a minimum of 6–9 years of experience
BS or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field.
Moderate pharmaceutical/medical device related experience.
Excellent interpersonal / communication skills including excellent written and verbal communication skills.
Excellent customer service skills, with the ability to work both as a team member and independently.
Good quality management skills.
Advanced skills in Microsoft Office Applications.
Fluent in speaking, writing, and reading English.

Benefits

Comp & perks

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself.

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory submissionsgap analysesproduct development planspost-approval maintenanceAPI variationsDrug Product variationssite transferCMC - Module 3Health Authority Questionsregulatory services

Soft Skills

interpersonal skillscommunication skillscustomer service skillscollaborationindependenceproblem-solvingteamworkquality managementpresentation skillsbusiness development