Regulatory Consultant

Syneos Health

Regulatory Consultant managing the preparation of regulatory submissions at Syneos Health. Supporting product development projects and ensuring compliance with global regulatory requirements.

Posted 7/2/2026full-timeGurugram • 🇮🇳 IndiaMid-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 trouble shooting 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.
Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
Prepare training materials and share best practices in the regulatory area, both internally and externally.
Participate as regulatory support in internal or external project audits.
Participate as regulatory support on internal cross-functional initiatives.
Contribute to the creation and/or maintenance of SOPs and other process related documentation as required.
Provide support in oversight to team members in the execution of their project responsibilities.
Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

Requirements

What you’ll need

Should have min 4-5 yrs of experience in regulatory affairs
should have Mpharm degree
Should have experience of CMC module 3
authoring of CMC sections of Post Approval variations and life cycle management activities
Should have in EU, GCC mkt experience.
Excellent interpersonal / communication skills including excellent written and verbal communication skills.
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

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Applicant Tracking System Keywords

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Hard Skills & Tools

Regulatory SubmissionsGap AnalysisProduct Development PlansSOP CreationLife Cycle ManagementProject ManagementRegulatory ComplianceTraining Material PreparationAudit ParticipationInterdisciplinary Collaboration

Soft Skills

Excellent Interpersonal SkillsEffective Communication Skills

Certifications

MPharm Degree