Senior Regulatory CMC Consultant – Small Molecule, Veeva RIM

. Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU .

Posted 9/25/2026full-timeRemote • Massachusetts • United States, CanadaSenior💰 $56,400 - $115,100 per yearWebsite

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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