Biologics RA-CMC position Experience range:4-15 years Function: Biologics, Regulatory Affairs
Position: Deputy Manager/Manager/Sr. Manager- Biologics Regulatory Affairs- CMC
Desired Qualification: M. Pharm /B. Pharm Desired Work Experience: Candidates having at Least 6 - 10 years of experience in US and EU market registrations for Biosimilar therapeutic proteins and Monoclonal Antibodies Alternatively, candidates having at least 8 - 10y exp in Small molecules injectables registrations for the US market with dossier authoring and query response for both drug substance and drug product. Job Responsibilities:
1. Biosimilar Regulated market submissions - US / EU regulatory submission. 2. Biosimilar Dossier Authoring (Drug substance and Drug product), MOH query response and Hands on experience in eCTD submissions
2. Biosimilar Product Development Strategy for CMC and Clinical development
3. Review of Quality documents including coordination with Cross functional teams ( R&D;, QC/QA and Manufacturing)
4. Biosimilar Product Life Cycle Management
5. RA support for Plant related QMS activities

📌 Biologics RA-CMC Deputy Manager/Manager/Sr. Manager- (Mumbai)
🏢 Boolean Staffing Recruitment Solutions
📍 Mumbai