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.