Parexel

Compensation

Full Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. 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. Exceptional opportunity for a highly experienced analytical chemist to partner with a large global biopharmaceutical client and lead regulatory CMC strategy for cutting‑edge peptide and oligonucleotide therapeutics. In this role, the Regulatory Affairs Senior/Consultant will drive global regulatory strategy and submission activities for complex synthetic and nucleic acid–based products, partnering closely with R&D, CMC, clinical, and quality teams to ensure compliance with international standards and accelerate successful product approvals. Qualifications & Experience Educational Background Bachelor’s or Master’s degree in chemistry, biochemistry, pharmaceutical sciences, or related discipline. Ph.D. in organic chemistry is preferred if possible. Technical & Regulatory Expertise 4-7 years in peptide or oligonucleotide synthesis, purification, and analytical testing (HPLC, LC-MS, NMR). Hands-on experience with solid-phase synthesis or phosphoramidite-based workflows. Familiarity with purity, identity, sequence confirmation, and impurity profiling requirements per FDA/ICH/USP standards. Regulatory & Professional Competencies Strong understanding of regulatory requirements for synthetic peptides and oligonucleotides and ability to analyze guidelines and precedents. Proven track record preparing CMC documents and regulatory submissions. Analytical, well-organized, and able to work across functions to resolve technical or compliance issues. Desired Skills Technical Skills Proficiency in chromatography (HPLC/UPLC), LC-MS, UV‑Vis, NMR, and sequence confirmation tools. Experience with automated or scale‑up synthesis platforms, lab instruments, and LIMS/electronic lab notebooks. Preferred Qualifications Experience with conjugation strategies (e.g., peptide-oligo, ligand-oligo constructs). Knowledge of global regulations (FDA, EMA, ICH) for biologics and oligo therapeutics. Process development or GMP exposure in peptide/oligo manufacturing settings. Based upon the location of this client partner, candidates located in EST are preferred. Consideration, however, will be given to exceptional candidates in other time zones located in the US and Canada. #LI-LB1 EEO 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. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™