inVentiv Health 0000101298-Regulatory Affairs Manager in Massachusetts
Under the general direction of the CMC Regulatory Affairs team, develop a Core Dossier for Module 2.3 and Module 3 CTD sections for a marketed product, and leverage the Core Dossier documents to support Marketing Authorization Applications for international regions. Manage preparation of Core Dossier and CMC components for international marketing applications in a timely manner to meet corporate objectives.
• 50% of the time develops global CMC Core Dossier for Module 2.3 and Module 3 CTD sections
• 50% of the time prepares CMC components of new Marketing Authorization Applications for international countries
• Bachelor’s degree in pharmacy, biochemistry, chemistry, biology or related pharmaceutical field.
• Minimum of 5 years of related experience within a pharmaceutical company, CRO or similar organization and with minimum of 2 years International/Global CMC regulatory experience in biologics/small molecule drug development and registration activities.
• Knowledgeable in ICH guidelines, Latin American CMC and core dossier requirement
• Ensures timely delivery of high quality regulatory submissions
• Must be highly organized, committed to excellence, and possess both determination and attention to detail.
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inVentiv Health, Inc. is an Equal Opportunity Employer, M/F/Disabled/Vets that values the strength that diversity brings to the workplace.