Senior Consultant, Regulatory Affairs (Small Molecules ...

Join our dynamic Global Regulatory Affairs team as a Senior Consultant in CMC Regulatory Affairs. This is an exciting opportunity for a driven professional looking to make a meaningful impact in the development and maintenance of investigational, new, and marketed small molecules and biologic products. You will help ensure that our clients comply with global regulatory requirements, focusing primarily on the United States, European Union, and Canada, with the aim of facilitating timely approvals and sustained market access. As a Senior Consultant, you will engage in both operational execution and strategic regulatory planning across a diverse portfolio of products. We are seeking a candidate who excels in collaborative environments and possesses a balanced mix of hands-on authoring expertise and forward-thinking regulatory insight. Key Responsibilities Strategic CMC Leadership: Provide regulatory strategy input for small molecule and biologic products, developing contingency plans for CMC-related scenarios, and representing CMC Regulatory Affairs in cross-functional project discussions. Submission & Documentation Excellence: Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions, while developing CMC strategies for product phases ranging from early development to marketing applications and post-approval changes. Cross-Functional Collaboration: Partner with manufacturing and quality teams, as well as external organizations, to address CMC-related issues. Cultivate collaborative relationships with internal stakeholders, contract manufacturers, packagers, and suppliers, and support Health Authority meeting planning. Process Optimization & Innovation: Identify and implement process improvements to enhance regulatory efficiency and readiness. Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions. Regulatory Systems & Reporting: Utilize regulatory systems and tools including CREDO and Trackwise Digital, ensuring audit readiness and version control through meticulous documentation and system management. Qualifications Experience & Expertise: 4-6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant role, or 7+ years for a Senior Consultant. Proven Success: Experience preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF). Deep Understanding: Knowledge of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules and biologics; experience with combination device products is a plus. Skills & Attributes: Strong strategic mindset with excellent operational execution, problem-solving, and negotiation abilities. Effective communication and leadership skills, with the capability to manage multiple projects independently in a matrixed, multicultural environment. Education: Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or a related field is required; advanced degrees (Pharm.D., M.S., Ph.D.) in relevant fields are preferred. RAC certification is an advantage. The ideal candidate will ideally reside in the Eastern Time Zone, but exceptional candidates from other time zones will also be considered, provided they can accommodate global meetings and calls as necessary. Parexel is proud to be an equal opportunity employer, ensuring that qualified applicants receive fair consideration without regard to legally protected status.

Created: 2026-03-04