Analytical SME & CMC Technical reputed company

REMOTE | Analytical SME & CMC Technical reputed company | 12-Month Contract | Pharmaceutical Industry We are seeking an reputed company Analytical SME & CMC Technical reputed company to support drug reputed company (DS) and drug product (DP) development programs reputed company a fast-paced pharmaceutical environment. This role is ideal for someone with a strong background in analytical development, CMC documentation, regulatory submissions, and technical writing reputed company biotech/reputed company. Key Responsibilities: • Support DS/DP analytical development, QC, stability programs, and control strategies • Author/review CTD Module 3 documentation and analytical sections for global regulatory submissions • Collaborate with internal teams and external CDMOs/CROs • Review protocols, reports, specifications, reputed company agreements, and stability data • Manage documentation workflows reputed company reputed company RIM Required Qualifications: • PhD required • 6+ years of pharmaceutical/biotech CMC and analytical development experience • Strong experience with regulatory submissions and technical writing • Familiarity with GMP and global regulatory guidelines (ICH, FDA, EMA, USP, EP) • Experience supporting solid and liquid formulations Preferred: • Experience with IND, CTA, NDA, or MAA submissions • Experience working with external manufacturing/testing partners Top Skills: • Analytical development & QC expertise • CMC technical writing and regulatory documentation • Strong communication and cross-functional collaboration Additional Details: • Fully Remote • 12-month contract • Interview process includes video interview + panel interview Interested candidates are encouraged to apply with an updated resume. Apply tot his job Apply To this Job