job summary: As the 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! location: Lexington, Massachusetts job type: Contract salary: $162.94 - 191.70 per hour work hours: 9 to 5 education: Bachelors responsibilities: We are seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business Unit. The Global Regulatory Affairs CMC & Device organization is responsible for global CMC regulatory strategies and activities (strategy & authoring) for the PDT BU product portfolio, market launch and product lifecycle management. The Strategist works in a highly matrixed, global product team-oriented environment and ensures close collaboration within the Global Regulatory Affairs CMC & Device organization and with other PDT BU functions and relevant company R&D functions to provide an effective and aligned regulatory CMC strategy and submission approach globally, regionally and locally The Strategist, Global Regulatory Affairs CMC, PDT BU is responsible for: Defining, coordinating and implementing global CMC regulatory strategies for product-specific development and life-cycle activitiesProviding proactive strategic guidance to the product-specific global regulatory and manufacturing sub-teams for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets.Manages the CMC regulatory strategy of high quality and compliant regulatory CMC documentation for the assigned product(s) within defined timelines as per R&D and business objectives.Advises on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with the business need and goals.Facilitates the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders.Identifies and recommends the most effective CMC regulatory strategies to assure a first-pass regulatory approval of initial application and lifecycle supplements/variations.Interfaces with key GMS and PDT BU R&D functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs.In collaboration with the network strategist, develops and manages timelines supporting regulatory submissions, proactively identifies risks and develops adequate risk management solutions in consultation with cross-functional teams.In collaboration with regional and local regulatory colleagues, critically evaluates CMC change controls to ensure all regulatory requirements to implement the change have been fully document in the respective quality management system.Provides tactical and strategic regulatory input and guidance, including active participation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations.Maintains an ongoing and interactive relationship with regional and local regulatory teams to assure that all aspects of the company's regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.Creates high quality, compliant regulatory CMC documents within defined timelines as per the company's PDT BU objectives. qualifications: 5-7 years' experienceBS skills: CMC, Regulatory Affairs Operations, Submissions 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.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).