Senior CMC Regulatory Affairs Consultant - Small Molecules
 Parexel International Corporation | |
 United States | |
 Jul 10, 2025 | |
|
When our values align, there's no limit to what we can achieve. 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. At the heart of every breakthrough therapy is a team of experts working in harmony. We're seeking a Senior CMC Regulatory Affairs Consultant who thrives in a collaborative environment and is passionate about guiding small molecule drug products through the complex global regulatory landscape. In this home-based role, you won't just be a subject matter expert-you'll be a trusted partner to cross-functional teams, helping to shape regulatory strategies that ensure timely approvals and sustained market access across the U.S., EU, and Canada. Your insights will empower teams, streamline development, and ultimately bring life-changing therapies to patients around the world. Position Responsibilities Include: - Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances, drug products, and drug-device combination products. - Determine regulatory and scientific/technical requirements for CMC and GMP related submissions and inquiries. -Represents CMC RA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with global regulatory lead(s). - Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements. - Develop and execute regulatory strategies for post approval changes for marketed products and communicate with respective cross-functional teams. Providing regulatory strategies on CMC changes for development phase products. - Prepare departmental job procedures. - Experience in CPP application filing through eCATS, 510(j)(3) reporting through nextGen portals is a plus. - Interact with manufacturing and quality groups, partner organizations, regarding CMC issues. - Independently manage preparation of INDs, BLAs, CTAs, amendments, supplements, and reports within company timelines and in accordance with regulations and guidelines. - Develop and maintain collaborative relationships with other local and/or global functional units [OPCJ CMC RA, Factory, Quality, MPDD, OPDC/OPEL Tech Ops] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc. - Participate in Health Authority CMC meeting preparations, rehearsals and/or meetings. - Assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges. - Independently handle monthly meetings with global cross-functional teams for assigned products. - Be proficient in the tools and systems needed for the function including and not limited to CREDO (doc management), ORIOM (regulatory information), Track Wise, TRS Viewer, Concur (expenses), and PowerPoint. - Performs other duties as assigned. Qualifications Knowledge: - Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues. - Knowledge of CMC regulatory requirements for small molecules during development and post-approval. Previous experience including biologic upstream and downstream processes, analytical methods, and drug/device combination products is a plus. - Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canda - Comprehensive understanding of the global regulatory environment. Skills: - Proactive strategic thinker - Operationally minded (know how to prepare a high-quality technical document or submission using internal systems - Strong analytical, problem solving, organizational and negotiation skills. - Strong collaborative inter-personal, communication, presentation and meeting leading skills. - Strong ability to work in matrixed environment and across cultural lines. - Strong ability to independently manage and prioritize a multi-project load - Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). Education: - Bachelors in Pharmaceutical Sciences or Chemistry or Pharm.D., Masters and Ph.D. preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biology - RAC certification a plus Experience: - 7 years or more of CMC regulatory experience in the pharmaceutical industry with a history of successful of investigational filings and approvals of marketing applications as the CMC Regulatory lead (prior experience with late-stage small molecule product CMC strategy is required) - Regulatory experience in handling-controlled substance applications will be a plus - Previous biologics experience is strongly preferred The ability to travel 10-15% may be required Candidates located in the EST are preferred due to the location of the client #LI-LB1 EEO Disclaimer | |