CMC Regulatory Affairs Consultant

8w2 months ago

Parexel

US · Contract · $180,000 – $250,000

About this role

At Parexel, we all share the same goal - to improve the world's health. 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. Every clinical development solution is underpinned by a deep conviction in what we do.

In this role, the Regulatory Affairs Senior/Consultant will drive global regulatory strategy and submission activities for complex synthetic and nucleic acid-based products. Partner closely with R&D, CMC, clinical, and quality teams. Ensure compliance with international standards and accelerate successful product approvals.

Each of us contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, do it with empathy, and are committed to making a difference. Work across functions to resolve technical or compliance issues.

When our values align, there's no limit to what we can achieve. Based upon the location of this client partner, candidates located in EST are preferred. Consideration given to exceptional candidates in other US and Canada time zones.

Requirements

Bachelor’s or Master’s degree in chemistry, biochemistry, pharmaceutical sciences, or related discipline (Ph.D. in organic chemistry preferred)
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
Strong understanding of regulatory requirements for synthetic peptides and oligonucleotides
Proven track record preparing CMC documents and regulatory submissions
Proficiency in chromatography (HPLC/UPLC), LC-MS, UV-Vis, NMR, and sequence confirmation tools
Analytical, well-organized, and able to work across functions

Responsibilities

Lead regulatory CMC strategy for cutting-edge peptide and oligonucleotide therapeutics
Drive global regulatory strategy and submission activities for complex synthetic and nucleic acid-based products
Partner closely with R&D, CMC, clinical, and quality teams
Ensure compliance with international standards
Accelerate successful product approvals
Prepare CMC documents and regulatory submissions
Analyze regulatory guidelines and precedents
Resolve technical or compliance issues across functions