Senior Consultant in Regulatory Affairs - Peptide and ...

Join a dynamic and innovative biopharmaceutical organization as a Senior Consultant in Regulatory Affairs, specializing in regulatory CMC strategy for groundbreaking peptide and oligonucleotide therapies. This is an exceptional opportunity for a seasoned analytical chemist to make a substantial impact on the biopharmaceutical industry. In this pivotal role, you will spearhead the development of comprehensive global regulatory strategies and oversee submission processes for advanced synthetic and nucleic acid-based products. Collaborating closely with R&D, CMC, clinical, and quality teams, you will ensure stringent compliance with international regulations, fast-tracking the journey to 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 valued. Technical & Regulatory Expertise 4-7 years of practical experience in peptide or oligonucleotide synthesis, purification, and analytical testing (HPLC, LC-MS, NMR). Hands-on experience with solid-phase synthesis or phosphoramidite-based methods. Thorough understanding of purity, identity, sequence confirmation, and impurity profiling standards per FDA/ICH/USP regulations. Regulatory & Professional Competencies Strong grasp of global regulatory frameworks for synthetic peptides and oligonucleotides, with an ability to analyze and effectively apply relevant guidelines. Demonstrated success in compiling CMC documentation and managing regulatory submissions. Detail-oriented, well-organized, and adept at cross-functional collaboration to address technical and compliance challenges. Desired Skills Technical Skills Expertise in chromatography (HPLC/UPLC), LC-MS, UV-Vis, NMR, and sequencing confirmation techniques. Familiarity with automated or scale-up synthesis systems, laboratory apparatus, and electronic lab notebooks (LIMS). Preferred Qualifications Understanding of conjugation strategies, including peptide-oligo and ligand-oligo constructs. Awareness of international regulations (FDA, EMA, ICH) related to biologics and oligonucleotide therapeutics. Experience in process development or GMP environments in peptide/oligonucleotide manufacturing. This position offers the flexibility of remote work. Exceptional candidates from diverse time zones within the U.S. and Canada will be considered, with preference given to those in the Eastern Standard Time zone. 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.

Created: 2026-03-12