Work as Regulatory Consulting Manger at Syneos Health

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Post : Regulatory Consulting Manger (Office based)

Job Description
• Contributes to planning for regulatory submissions in assigned region/country/project.
• Responsible for day to day management of project teams and projects.
• Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
• Acts as a representative of the regulatory department with other departments.
• Supports business development, including generation of repeat business from existing clients and proposal development.
• develops, reviews, and monitors project budgets; reviews client invoicing.
• Monitors personal utilization and utilization of direct reports.
• Acts as a key point of contact for clients and regulatory authorities.
• Provides regulatory advice to Company associates.
• Conducts regulatory research on projects as needed.

• Provides strategic and operational advice to clients.
• Arranges, leads, and reports on client and regulatory agency meetings.
• Writes IND and product registration dossiers, clinical reports, and other regulatory documents. Manages project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post approval maintenance activities.
• Acts as a resource for technical knowledge.
• Participates in quality improvement efforts to increase overall operational efficiency.
• Contributes to the building of regulatory systems and infrastructure needed for GRAS.
• Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.
• Develops solutions to complex problems.
• Provides internal training in appropriate areas of expertise to other departments.

Candidate Profile
• 4-5 years of experience in Regulatory Affairs. (IND- Gurugram / Hyderabad)
• M.Pharm qualification is mandatory.
• Experience as a Regulatory Lead managing a product portfolio.
• Hands-on experience in CMC authoring, post-approval variations, and lifecycle management activities.
• Experience evaluating post-approval CMC change controls.
• Regulatory exposure to EU, GCC, and AU markets; APAC or US experience is an added advantage.
• Prior experience in team handling/people management

Additional Information
Experience : 4-5 years
Qualification : M.Pharm
Location : Gurugram
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory
End Date : 30th October 2026