Major Duties and Responsibilities:
• Review production batch records and executed batch records for DS and DP
• Review proposals, protocols, investigations, validation and study reports
• Review and prepare regulatory CMC documents, as necessary, including CMC sections of NDA and MAA submissions, annual reports, etc.
• Monitor, review and approve stability data
• Prepare data summaries, technical reports, risk assessments, etc.
• Review and prepare SOPs and assist in preparations for Pre-Approval Inspections by Regulatory Authorities
• Provide assistance in preparation and maintenance of CMC budget
• Assist to monitor CMC activities performed at CMOs, including participation in conference calls during evening hours
• Support other CMC functions as required
Reports To:
VP, CMC
Qualification Requirements:
• BSc. or MSc. in Chemistry, Pharmacist or Chemical Engineer
• At least 5 years of experience in the Pharmaceutical Industry
• Fluent in English, with good writing skills
• Organized and systematic, with good eye for detail
• Good interpersonal relationships and team-player, motivated and hard worker
• Experience with regulatory submissions- advantage
• Experience with peptide synthesis- advantage
• Experience in process validation, and in Phase 3 and commercial products- advantage
• Experience in managing outsourced activities and in working with CMOs/CROs-advantage
