Senior Regulatory Consultant – LATAM, Biologics, CTA

. Support execution of multi-product global regulatory CMC for marketed products .

Posted 9/25/2026full-timeRemote • Argentina, Mexico, Colombia, BrazilSeniorWebsite

Key responsibilities & impact

Support execution of multi-product global regulatory CMC for marketed products
Contribute to preparation and submission of regulatory CMC documentation
Provide regulatory support to various cross-functional teams
Execute commercial Lifecycle Management strategy and submissions focused on US, Canada and EU
Review CMC sections of regulatory submissions and 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 when applicable

What you’ll need

Bachelor's degree, with a preference 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
Proficiency in regulatory FDA, EMA, Health Canada and ICH guidelines
Strong interpersonal skills to exchange complex information with others and to guide others
Strong problem-solving skills
Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
Strong sense of planning and prioritization, and the ability to work with all levels of management
Sound knowledge of cGMP, FDA, EMA, ICH
Biologics and CTA experience required by the job title

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Reasonable accommodations, when appropriate, under the Americans with Disabilities Act