# Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM

**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/ARG-Remote/Mgr-Sr-Regulatory-CMC-Consultant---Small-Molecule---Veeva-RIM-Must-Have_25111443?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_4e0bf86e-cf7

## Description

We are seeking a Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM to join our team in EMEA/LATAM/Canada.

As a Mgr/Sr Regulatory CMC Consultant, you will contribute to planning for regulatory submissions in assigned region/country/project. You will be responsible for day-to-day management of project teams and projects, including line management responsibilities for staff members.

Key responsibilities include:

- 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

Benefits:

- Career development and progression

- Supportive and engaged line management

- Technical and therapeutic area training

- Peer recognition and total rewards program

- Inclusive culture

## Skills

### Required
- regulatory submissions
- project management
- line management
- regulatory advice
- business development

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/ARG-Remote/Mgr-Sr-Regulatory-CMC-Consultant---Small-Molecule---Veeva-RIM-Must-Have_25111443?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)