CMC Regulatory Affairs Senior/Consultant - Small ...

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 clientu2019s 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 u2022 Provide regulatory strategy input for small molecules (previous experience with biologics and/or drug-device combination products are a plus) u2022 Support regulatory leads in developing contingency plans for CMC-related scenarios u2022 Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads Submission & Documentation Excellence u2022 Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions u2022 Develop CMC strategies for products across all phasesu2014from early development to marketing applications and post-approval changes Cross-Functional Collaboration u2022 Partner with manufacturing, quality, and external organizations to address CMC-related issues u2022 Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers u2022 Support planning and execution of Health Authority meetings, including mock sessions Process Optimization & Innovation u2022 Identify and implement process improvements to enhance regulatory efficiency and readiness u2022 Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions u2022 Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer Regulatory Systems & Reporting u2022 Experience with CPP application filing via eCATS and 510(j)(3) reporting through nextGen portals is a plus u2022 Ensure audit readiness and version control through meticulous documentation and system management Qualifications Experience & Expertise u2022 4u20136 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant u2022 Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF) u2022 In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules. Previous experience with biologics or combination device products are a plus Skills & Attributes u2022 Strategic and proactive mindset with strong operational execution u2022 Excellent analytical, problem-solving, and negotiation skills u2022 Effective communicator with strong interpersonal, presentation, and leadership abilities u2022 Ability to manage multiple projects independently in a matrixed, multicultural environment u2022 Proficiency in Microsoft Office Suite and regulatory systems Education u2022 Bacheloru2019s degree in Pharmaceutical Sciences, Chemistry, or related field u2022 Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred u2022 RAC certification is a plus 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. #LI-LB1 #LI-REMOTEEEO 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.

Created: 2025-11-01