CMC Regulatory Affairs Senior / Consultant - Small Molecules

Cmc Regulatory Affairs Senior / Consultant

Exciting opportunity for an experienced and highly motivated professional to join our global regulatory affairs team. 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)
• 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 on other time zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.

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.