job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation. location: Cambridge, Massachusetts job type: Contract salary: $83.42 - 98.14 per hour work hours: 9 to 5 education: Bachelors responsibilities: Under the direction of the Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing a Core Dossier for Module 3 and preparing Module 3 documents to support Marketing Authorization Applications in Japan and Brazil. Provide support to other HA interactions as required. Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into submissions for marketing authorizations.Provide Reg CMC support for development programs to ensure that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned.Manage preparation of Core Dossier, Japan and Brazil applications in a timely manner to meet corporate objectives. Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives. 30%: Develop global CMC Core Dossier for Module 3 20%: Prepare Module 3 Marketing Authorization Application for Japan 30%: Prepare Module 3 Marketing Authorization Application for Brazil. 10%: Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines. 10%: Provide CMC regulatory guidance to project / product teams. qualifications: B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology or related pharmaceutical field. Minimum of 4 years experience in pharmaceutical product development including significant experience in CMC regulatory affairs with a strong biologics background or equivalent.Experience in directing interactions with regulatory authorities desired.Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance. Significant coordination with cross-functional teams internally and regulatory authorities externally. skills: CMC, FDA, GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Submissions, ICH Regulations Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.