Remote CMC Affairs Senior Consultant

Jobgether • Washington, DC

12h • Remote

About The Position

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior CMC Regulatory Affairs Consultant - REMOTE. In this critical role, you will partner with a large global biopharmaceutical client to guide regulatory CMC strategies for innovative peptide and oligonucleotide therapies. Your expertise will not only impact the compliance of these complex products but also enhance the likelihood of successful approvals, ultimately benefiting patient health. This opportunity offers a platform to utilize your five years of experience with synthetic products in a collaborative environment, working closely with interdisciplinary teams to drive regulatory success and innovation.

Requirements

• Bachelor’s or Master’s degree in chemistry, biochemistry, pharmaceutical sciences, or related field; Ph.D. preferred.
• 4-7 years of experience in peptide or oligonucleotide synthesis, purification, and analytical testing.
• Hands-on experience with solid-phase synthesis or phosphoramidite-based workflows.
• Strong understanding of regulatory requirements for synthetic peptides and oligonucleotides.
• Proficiency in analytical techniques such as HPLC, LC-MS, and NMR.

Responsibilities

• Drive global regulatory strategy and submission activities for peptide and nucleic acid-based products.
• Collaborate with R&D, CMC, clinical, and quality teams to ensure compliance with international standards.
• Prepare CMC documents and regulatory submissions for complex products.
• Lead regulatory interactions with health authorities.
• Analyze and interpret regulatory guidelines and precedents.

Benefits

• Work in a fully remote capacity with flexible hours.
• Opportunity to collaborate with global teams in a meaningful field.
• Professional development opportunities to enhance your skills.
• Participate in projects that significantly impact patient health.
• Enjoy a supportive and inclusive company culture.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level