Description
Syneos Health is seeking a Sr Regulatory Consultant (CMC, EU mkt) to join their team.
The successful candidate will have 6-9 years of Regulatory Affairs experience, preferably in biologics, with strong expertise in authoring and reviewing Module 3 CMC sections for post-approval variations and lifecycle activities.
Key responsibilities include:
- Contributing to project teams and projects on a day-to-day basis
- Acting as a representative of the GRAS regulatory department with other departments
- Providing technical expertise to proposals and assisting with Business Development initiatives
- Understanding project budgets, scope of projects, allocated hours, and tracking compliance
- Interacting with internal and external personnel, clients, and technical experts on projects
- Conducting regulatory research on projects as needed
- Preparing consulting reports under guidance
- Arranging, leading, and reporting on client meetings
- Contributing to regulatory agency meetings
- Writing IND and product registration dossiers, clinical reports, and other regulatory documents for submissions
- Preparing full regulatory submissions for 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 the regulatory systems and infrastructure needed for GRAS
- Developing a reputation for the Company as an industry leader in Regulatory
- Providing internal training in appropriate areas of expertise to other Departments
The ideal candidate will have:
- A BS degree, preferably in a science-related field or equivalent experience
- Moderate regulatory, pharmaceutical/medical device related experience
- Demonstrated experience in contributing to the preparation of regulatory submissions
- Excellent interpersonal and communication skills
- Excellent customer service skills
- Good quality management skills
- Problem-solving and decision-making skills
- Advanced skills in Microsoft Office Applications
- Ability to interact with staff from multiple departments and offices
- Good initiative, adaptability, and pro-activity
- Strong analytical skills and attention to detail
- Ability to work concurrently on projects
- Fluent in speaking, writing, and reading English