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

**Company**: Syneos Health
**Experience**: senior
**Job type**: full-time
**Salary**: $56,400.00 - $115,100.00
**Category**: Consulting
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/USA-MA-Remote/Mgr-Sr-Regulatory-CMC-Consultant---Small-Molecule---Veeva-RIM-Must-Have_25112893?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_0acf926e-759

## Description

As a Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM at Syneos Health, you will execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU.

Key responsibilities include:

- Reviewing CMC sections of regulatory submissions, as well as interactions and responses with regulatory agencies

- Working with regulatory colleagues to develop global regulatory CMC strategies and submissions

- Participating effectively on cross-functional teams and serving as the primary regulatory CMC contact for assigned products and projects

Requirements:

- Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field

- Typically 4 years of experience in the pharmaceutical industry or related field, or equivalent combination of education and experience

- Preferred experience supporting Small Molecule programs

Syneos Health offers a range of benefits, including:

- Company car or car allowance

- Health benefits, including Medical, Dental, and Vision

- Company match 401k

- Eligibility to participate in Employee Stock Purchase Plan

- Eligibility to earn commissions/bonus based on company and individual performance

- Flexible paid time off (PTO) and sick time

The salary range for this position is $56,400.00 - $115,100.00.

## Skills

### Required
- regulatory submissions
- CMC strategy
- global regulatory affairs
- interpersonal skills
- problem-solving skills
- planning and prioritization
- cGMP
- FDA
- EMA
- ICH

### Nice to have
- Small Molecule programs

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/USA-MA-Remote/Mgr-Sr-Regulatory-CMC-Consultant---Small-Molecule---Veeva-RIM-Must-Have_25112893?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)