Manager Regulatory Affairs-CMC

Job Title: Manager Regulatory Affairs-CMC Location: Lexington, MA Duration: 4+months (Possibility of extension) Business Function: R&D Department Name: Global Regulatory Affairs Primary Role: 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. Responsibilities: 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 EDUCATION & EXPERIENCE Requirements: 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. Key Skills and Competencies: 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. We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job. Thanks & Regards, Seema Chawhan Clinical Recruiter Integrated Resources , Inc. IT Life Sciences Allied Healthcare CRO Certified MBE | GSA - Schedule 66 I GSA - Schedule 621I DIRECT # - 732-844-8724 LinkedIn: Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5 0 0 0 ’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row) Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.