CMC Regulatory Affairs Senior / Consultant - Small Molecules

Overview

Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior / Consultant. This role is critical to ensure our client's investigational, new, and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United States, European Union, and Canada, with a focus on facilitating timely approvals and supporting continued market access.

Key Responsibilities

• Strategic CMC Leadership

Provide regulatory strategy input for small molecules (previous experience with biologics and / or drug-device combination products are a plus)

Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions

Partner with manufacturing, quality, and external organizations to address CMC-related issues

Identify and implement process improvements to enhance regulatory efficiency and readiness

Experience with CPP application filing via eCATS and 510(j)(3) reporting through nextGen portals is a plus

Qualifications

4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant

Strategic and proactive mindset with strong operational execution

Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field

Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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