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Mansueto Ventures is home to two of the most iconic and vibrant brands in business publishing: Inc. and Fast Company. Every day, the content, awards, and events produced help entrepreneurs and innovators succeed by providing useful insights, sparking essential conversations, and offering much-needed inspiration.

Inc. is the voice of the American entrepreneur, inspiring and documenting the risk-takers and ultra-driven go-getters who represent the most dynamic force in the American economy.
Fast Company is the world’s leading business media brand, focusing on innovation in technology, leadership, and design to inspire readers to shape the future of business.

","New York, NY","coloredLogo","logoAttachment","thumbnail","thumbnailAttachment","hexCode","#080D0C","headline","Publisher of Inc. and Fast Company, empowering innovators and entrepreneurs.","/companies/mansueto-ventures-careers","hasJobSubmission","isSavedJob","similarJobs",[511,517,525,536,542],{"_429":428,"_434":512,"_452":453,"_444":445,"_243":438,"_441":438,"_427":428,"_111":437,"_431":432,"_433":194,"_454":453,"_442":513,"_425":514,"_455":456,"_430":115,"_476":477,"_460":515,"_478":479,"_480":513,"_482":483,"_484":516,"_486":487},["D",1771113600000],"Atlanta, GA, US, 30383",["B","2619532733"],"/jobs/2619532733-cmc-regulatory-affairs-consultant-with-experience-in-peptides-and-oligonucleotid","/jobs?location=Atlanta%2C+GA%2C+US%2C+30383",{"_429":428,"_434":518,"_452":453,"_444":445,"_243":438,"_441":438,"_427":428,"_111":519,"_431":432,"_433":194,"_454":453,"_442":443,"_425":520,"_455":456,"_430":115,"_476":521,"_460":522,"_478":523,"_480":443,"_482":483,"_484":485,"_486":524},["D",1771200000000],"Senior CMC Regulatory Affairs Consultant - Peptides and Oligonucleotides",["B","2619517009"],"3 days ago","/jobs/2619517009-senior-cmc-regulatory-affairs-consultant-peptides-and-oligonucleotides","Senior CMC Regulatory Affairs Consultant - Peptides and Oligonucl...","/jobs?keyword=Senior+CMC+Regulatory+Affairs+Consultant+-+Peptides+and+Oligonucl...",{"_429":428,"_434":526,"_452":453,"_444":527,"_243":528,"_441":529,"_427":428,"_111":437,"_431":194,"_433":194,"_454":453,"_442":530,"_425":531,"_455":532,"_430":115,"_476":477,"_460":533,"_478":479,"_480":530,"_482":534,"_484":535,"_486":487},["D",1771142400000],"Parexel International","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, 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.

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.

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