About the role

Regulatory CMC consultant guiding small-molecule submissions and global compliance strategies. Supporting life-sciences customers through regulatory agency interactions and cross-functional programs.

Responsibilities

Support the execution of global regulatory CMC strategies for marketed and development products
Contribute to the preparation and submission of regulatory CMC documentation for small molecules
Review CMC sections of regulatory submissions, interactions, and responses with regulatory agencies
Contribute to global regulatory CMC strategies for commercial products
Work with regulatory colleagues to develop global regulatory CMC strategies and submissions
Provide regulatory CMC guidance to cross-functional teams and key stakeholders
Support regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations

Strong interpersonal skills to exchange complex information with others and to guide others
Proficiency in regulatory FDA, EMA, Health Canada, LATAM, Middle East, and ICH guidelines
Experience in the preparation, including writing, of CMC submissions
Strategic thinking and strong problem-solving skills
Ability to collaborate and communicate in an open, clear, complete, timely, and consistent manner
Strong planning and prioritization skills
Ability to work with all levels of management
Ability to resolve complex and ambiguous situations
Sound knowledge of cGMP, FDA, EMA, and ICH
Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
Equivalent experience, skills, and/or education may be considered

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