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Senior Regulatory CMC Consultant – Small Molecule, Veeva RIM
Posted 4 days ago
About the role
- Regulatory CMC Consultant guiding small-molecule submissions and Veeva RIM activities. Supporting Syneos Health’s integrated life-sciences and drug-development services.
Responsibilities
- Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU
- Review CMC sections of regulatory submissions, interactions, and responses with regulatory agencies
- Work with regulatory colleagues to develop global regulatory CMC strategies and submissions
- Participate effectively on cross-functional teams
- Serve as the primary regulatory CMC contact for assigned products and projects
Requirements
- Bachelor's degree, preferably in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
- Typically requires 4 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience
- Preferred experience supporting Small Molecule programs
- Must-have experience with Veeva RIM
- Proficiency in FDA, EMA, Health Canada, and ICH regulatory guidelines
- Sound knowledge of cGMP, FDA, EMA, and ICH
- Strong interpersonal, problem-solving, collaboration, communication, planning, and prioritization skills
- Ability to work with all levels of management
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Company car or car allowance
- Medical, dental, and vision benefits
- Company match 401(k)
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time
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