Description
Syneos Health is seeking a Regulatory Consultant (CMC-EU, GCC & AU) to join their team.
The successful candidate will have exposure to CMC authoring, specifically authoring CTD Module 3 (M3) sections independently, and experience with post-approval variations/supplements, cross-functional interaction with analytical, formulation, and manufacturing teams, CMC writing, and lifecycle management for small molecules.
Key Responsibilities:
- Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
- Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance.
- Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned projects according to agreed timelines, scope of contract, budgets, and strategies.
- Participate as regulatory support on multidisciplinary project teams to develop products throughout their life cycle.
- Act as a subject matter expert and help team members with day-to-day troubleshooting activities, presenting solutions to project-related problems.
- Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
- Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
- Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
- Prepare training materials and share best practices in the regulatory area, both internally and externally.
- Participate as regulatory support in internal or external project audits.
- Participate as regulatory support on internal cross-functional initiatives.
- Contribute to the creation and/or maintenance of SOPs and other process-related documentation as required.
- Provide support in oversight to team members in the execution of their project responsibilities.
- Capable of identifying when to ensure line support required to provide additional guidance and direction.
- Maintenance of individual training records (Syneos Health or client-related) and completion of all designated required training.
Mandatory Skillsets:
- CMC authoring exposure, authored CTD Module 3 (M3) sections independently.
- Experience with post-approval variations/supplements.
- Cross-functional interaction with analytical, formulation, and manufacturing teams.
- CMC writing and lifecycle management for small molecules.
- Experience across: EU, USFDA, AU, GCC, ROW.
The ideal candidate will be able to:
- Own CTD sections
- Interpret technical data
- Write content from raw CMC documents
- Defend content in authority queries
- Know section numbers and expectations