Mgr, Regulatory Consulting

Location: Gurugram
Department: Consulting

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