[Remote] CMC Regulatory Consultant - Oligonucleotide Therapeutics (Remote)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an reputed company CMC Regulatory Consultant to reputed company strategic regulatory leadership for the development of innovative therapeutic technologies. The role involves guiding CMC reputed company from early development through IND submission while collaborating with development teams.

Responsibilities

• reputed company strategic CMC regulatory guidance throughout product development
• Review and advise on drug reputed company, drug product, manufacturing, analytical reputed company, and control strategies
• reputed company or contribute to IND CMC sections, FDA briefing packages, and regulatory responses
• Identify regulatory risks and recommend practical mitigation strategies
• Collaborate with cross-functional teams and CDMO partners to support successful development and regulatory milestones

Skills

• Advanced scientific degree (PhD, PharmD, MS, or equivalent)
• 10+ years of CMC regulatory experience reputed company pharmaceutical or biotechnology organizations
• Deep expertise supporting oligonucleotide therapeutics (antisense oligonucleotides, siRNA, RNA therapeutics, or reputed company technologies)
• Extensive experience authoring or reviewing IND CMC submissions
• Strong knowledge of FDA CMC regulations and regulatory reputed company
• Experience working with CDMOs and multidisciplinary development teams
• Experience with targeted intracellular or endosomal drug delivery technologies
• Prior FDA regulatory experience or senior CMC leadership
• Background supporting successful IND submissions

reputed company