Sr. CMC Regulatory Specialist; Remote
Position: Sr. CMC Regulatory Specialist (Remote)
Location: California
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.
Accountabilities
⢠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.
Requirements
⢠Bachelorâs or Masterâs 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.
⢠Handsâon experience with solidâphase synthesis or phosphoramiditeâbased workflows.
⢠Strong understanding of regulatory requirements for synthetic peptides and oligonucleotides.
⢠Proficiency in analytical techniques such as HPLC, LC-MS, and NMR.3>
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 andli>
Why Apply Through Jobgether?
We use an AIâpowered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the topâfitting candidates shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice:
By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and preâcontractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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Apply Now
Apply Now
Location: California
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.
Accountabilities
⢠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.
Requirements
⢠Bachelorâs or Masterâs 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.
⢠Handsâon experience with solidâphase synthesis or phosphoramiditeâbased workflows.
⢠Strong understanding of regulatory requirements for synthetic peptides and oligonucleotides.
⢠Proficiency in analytical techniques such as HPLC, LC-MS, and NMR.3>
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 andli>
Why Apply Through Jobgether?
We use an AIâpowered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the topâfitting candidates shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice:
By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and preâcontractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
#J-18808-Ljbffr
Apply Now
Apply Now