# Mgr, Regulatory Consulting **Company**: Syneos Health **Location**: Gurugram **Work arrangement**: hybrid **Experience**: senior **Job type**: full-time **Category**: Consulting **Industry**: Healthcare **Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Gurugram-Hybrid/Mgr--Regulatory-Consulting--Office-based-_25112535-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_8f5a22ec-e1e ## Description Syneos Health is seeking a Mgr, Regulatory Consulting to join their team. The successful candidate will contribute to planning for regulatory submissions in assigned region/country/project, responsible for day-to-day management of project teams and projects, and provide line management responsibilities for staff members. Key responsibilities include: - Managing a product portfolio as a Regulatory Lead - Hands-on experience in CMC authoring, post-approval variations, and lifecycle management activities - 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 - Contributing 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 - Acting as a representative of the regulatory department with other departments - Supporting business development, including generation of repeat business from existing clients and proposal development - Developing, reviewing, and monitoring project budgets; reviewing client invoicing - Monitoring personal utilization and utilization of direct reports - Acting as a key point of contact for clients and regulatory authorities - Providing regulatory advice to Company associates - Conducting regulatory research on projects as needed - Providing strategic and operational advice to clients - Arranging, leading, and reporting on client and regulatory agency meetings - Writing IND and product registration dossiers, clinical reports, and other regulatory documents - Managing project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post-approval maintenance activities - Acting as a resource for technical knowledge - Participating in quality improvement efforts to increase overall operational efficiency - Contributing to the building of regulatory systems and infrastructure needed for GRAS - Developing reputation for the Company as industry leader in Regulatory by attending and speaking at industry events - Developing solutions to complex problems - Providing internal training in appropriate areas of expertise to other departments The ideal candidate will have: - M.Pharm qualification - 4-5 years of experience in Regulatory Affairs - Demonstrated experience in contributing to the preparation of regulatory submissions - Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development - Excellent interpersonal/communication skills - Excellent customer service skills - Good quality management and budgeting skills - Good people management, project management, problem-solving, and decision-making skills - Advanced skills in Microsoft Office Applications - Ability to interact with staff from multiple departments and offices to establish project standards - Good initiative, adaptability, and pro-activity - Strong analytical skills, good attention to detail - Ability to work concurrently on projects, each with specific instructions that may differ from project to project - Fluent in speaking, writing, and reading English ## Skills ### Required - Regulatory Affairs - CMC authoring - post-approval variations - lifecycle management - team management - regulatory submissions - project management - budgeting - analytical skills ### Nice to have - regulatory exposure to EU, GCC, and AU markets - APAC or US experience - ODD - PIP/PMP --- Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Gurugram-Hybrid/Mgr--Regulatory-Consulting--Office-based-_25112535-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)