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