Job Details

Join a leading global biopharmaceutical company as a Senior Regulatory Affairs Consultant, focusing on regulatory CMC strategy for pioneering peptide and oligonucleotide therapies. This is a remarkable opportunity for an experienced analytical chemist to significantly influence the biopharmaceutical landscape.

In this key role, you will lead the development of global regulatory strategies and manage submission processes for sophisticated synthetic and nucleic acid-based products. You will work collaboratively with R&D, CMC, clinical, and quality teams to ensure compliance with international regulations, accelerating the pathway to successful product approvals.

Qualifications & Experience

• Educational Background
• Bachelor's or Master's degree in chemistry, biochemistry, pharmaceutical sciences, or a related discipline. A Ph.D. in organic chemistry is highly preferred.
• Technical & Regulatory Expertise
• 4-7 years of hands-on experience in peptide or oligonucleotide synthesis, purification, and analytical testing (HPLC, LC-MS, NMR).
• Practical experience with solid-phase synthesis or phosphoramidite-based workflows.
• In-depth knowledge of purity, identity, sequence confirmation, and impurity profiling standards in accordance with FDA/ICH/USP regulations.
• Regulatory & Professional Competencies
• Strong command of global regulatory frameworks for synthetic peptides and oligonucleotides, with the ability to analyze and apply relevant guidelines effectively.
• Proven track record in compiling CMC documentation and regulatory submissions.
• Detail-oriented, organized, and skilled in cross-functional collaboration to resolve technical and compliance challenges.

Desired Skills

• Technical Skills
• Proficient 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.
• Knowledge of international regulations (FDA, EMA, ICH) related to biologics and oligonucleotide therapeutics.
• Experience in process development or GMP settings in peptide/oligonucleotide manufacturing.

This position allows for remote work. Exceptional candidates from various time zones within the U.S. and Canada will be considered, with priority 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.