Senior CMC Regulatory Affairs Consultant - Peptides and Oligonucleotides

Join a prestigious global biopharmaceutical firm as a Senior Regulatory Affairs Consultant, specializing in the regulatory CMC strategy for innovative peptide and oligonucleotide therapeutics. This is a unique opportunity for a seasoned analytical chemist to make a significant impact in the industry. In this role, you will spearhead global regulatory strategies and submission activities for complex synthetic and nucleic acid-based products. Collaborate closely with R&D, CMC, clinical, and quality teams to ensure adherence to international compliance standards and expedite successful product approvals. Qualifications & Experience Educational Background Bachelor's or Master's degree in chemistry, biochemistry, pharmaceutical sciences, or a related field. A Ph.D. in organic chemistry is highly preferred. Technical & Regulatory Expertise 4-7 years of experience in peptide or oligonucleotide synthesis, purification, and analytical testing (HPLC, LC-MS, NMR). Hands-on experience with solid-phase synthesis or phosphoramidite-based workflows. Comprehensive knowledge of purity, identity, sequence confirmation, and impurity profiling standards in alignment with FDA/ICH/USP requirements. Regulatory & Professional Competencies Strong understanding of regulatory frameworks for synthetic peptides and oligonucleotides, along with the ability to interpret guidelines and precedents effectively. Demonstrated success in preparing CMC documentation and regulatory submissions. Analytical, organized, and adept at cross-functional collaboration to address technical and compliance issues. Desired Skills Technical Skills Expertise in chromatography (HPLC/UPLC), LC-MS, UV-Vis, NMR, and sequencing confirmation methodologies. Experience with automated or scale-up synthesis systems, laboratory instruments, and electronic lab notebooks (LIMS). Preferred Qualifications Familiarity with conjugation strategies, including peptide-oligo and ligand-oligo constructs. Knowledge of global regulations (FDA, EMA, ICH) pertaining to biologics and oligonucleotide therapeutics. Experience in process development or GMP environments related to peptide/oligonucleotide manufacturing. This position allows for remote work, with priority given to candidates located in the Eastern Standard Time zone, but exceptional candidates from other U.S. and Canadian time zones will also be considered. #LI-LB1 #LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, including race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.