Cutting Edge Peptide And Oligonucleotide Therapeutic Strategy Consultant - Ontario - beBeeBiopharmaceutical

    beBeeBiopharmaceutical
    beBeeBiopharmaceutical Ontario

    1 week ago

    Job title: CMC Regulatory Affairs Consultant with experience in peptides and oligonucleotides

    Description

    Unlock Your Potential in Regulatory Affairs

    We are seeking a highly experienced and skilled Regulatory Affairs Specialist to lead our team's regulatory strategy for cutting-edge peptide and oligonucleotide therapeutics.

    In this key role, you will partner closely with R&D, CMC, clinical, and quality teams to ensure compliance with international standards and accelerate successful product approvals.


    Ideal Candidate Profile:



    • Bachelor's or Master's degree in chemistry, biochemistry, pharmaceutical sciences or related field; Ph.D. in organic chemistry preferred;

    • 4-7 years of experience in peptide or oligonucleotide synthesis purification analytical testing (HPLC LC MS NMR); solid-phase synthesis phosphoramidite-based workflows; purity identity sequence confirmation impurity profiling requirements per FDA ICH USP standards;

    • Familiarity with global regulations biologics oligo therapeutics experience conjugation strategies e.g., peptide-oligo ligand-oligo constructs process development GMP exposure manufacturing settings)


    The ideal candidate is analytical well-organized able work across functions resolve technical compliance issues;

    We offer exceptional opportunities professional growth competitive compensation benefits package leading the industry;
    Parexel is an equal opportunity employer qualified applicants receive consideration employment without regard legally protected status which includes race color religion sex sexual orientation gender identity national origin disability veteran status.EEO Disclaimer[1]

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