CMC Regulatory Affairs Senior / Consultant - Small Molecules & Biologics

Parexel Regulatory Affairs Senior / Consultant

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 biologic and 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 biologics and small molecules (previous experience with drug-device combination products is a plus)
• Support regulatory leads in developing contingency plans for CMC-related scenarios
• Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads

Submission & Documentation Excellence

Cross-Functional Collaboration

Process Optimization & Innovation

Regulatory Systems & Reporting

Qualifications

Experience & Expertise

Skills & Attributes

Education

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.