# Regulatory Consultant (CMC-EU, GCC & AU)

**Company**: Syneos Health
**Experience**: senior
**Job type**: full-time
**Category**: Consulting
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Remote/Regulatory-Consultant--CMC-EU--GCC---AU-_25110577?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_a9bcbfb5-221

## 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

## Skills

### Required
- CMC authoring
- CTD Module 3
- post-approval variations
- supplements
- analytical
- formulation
- manufacturing teams
- CMC writing
- lifecycle management
- small molecules
- EU
- USFDA
- AU
- GCC
- ROW

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Remote/Regulatory-Consultant--CMC-EU--GCC---AU-_25110577?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)